Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.52 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Dose descriptor starting point:
NOAEL
Value:
50 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
88 mg/m³
Explanation for the modification of the dose descriptor starting point:

A DNEL has been derived (adjusted for route-route differences) according to ECHA guidance from oral sub-chronic repeated dose toxicity data, on DAP a closely related structural analogue. There were no systemic long term inhalation study data available. The data are taken from a 13 weeks 5 days/week oral gavage study (NTP, 1985) in the rat in which hepatocellular periportal necrosis, fibrosis, cirrhosis and bile duct hyperplasia were present.

The NOAEL was identified at 50 mg/kg/day.

Modification of dose descriptor:

Convert the rat oral NOAEL into a human inhalation NOAEC (mg/m3) after adjusting for differences in uptake between the two routes using a default factor of 1 (100% oral/100% inhalation). Oral absorption of diallylphthalate is extensive (Eigenberg et al 1986) so assumption of 100% oral absorption and 100% inhalation absorption is appropriate. CorrectedNOAECinhalation = Oral NOAEL x [1/ sRVrat] x [ABSoral-rat/ABSinhal-human] x [sRVhuman/wRV] CorrectedNOAECinhalation = 50 x [1/0.38] x [100/100] x [6.7/10] = 88 mg/m3

AF for dose response relationship:
1
Justification:
ECHA REACH Guidance (Clear NOAEL with no uncertainties in the dose descriptor)
AF for differences in duration of exposure:
2
Justification:
ECHA REACH Guidance (Subchronic to chronic AF)
AF for interspecies differences (allometric scaling):
1
Justification:
ECHA REACH Guidance (Effects not dependent on metabolic rate)
AF for other interspecies differences:
2.5
Justification:
ECHA REACH Guidance (Default AF for systemic effects)
AF for intraspecies differences:
5
Justification:
ECHA REACH Guidance (Default AF for workers)
AF for the quality of the whole database:
1
Justification:
ECHA REACH Guidance (Default AF for good quality data)
AF for remaining uncertainties:
1
Justification:
ECHA REACH Guidance
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
6.22 mg/m³
Most sensitive endpoint:
acute toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
62.5
Modified dose descriptor starting point:
other: LC 1
Value:
580 mg/m³
Explanation for the modification of the dose descriptor starting point:

DN(M)EL related information It may be necessary to derive a DNEL for acute/short term inhalation exposure since there is an acute toxicity hazard leading to classification and labelling for diallylphthalate and therefore DAIP according to 1278/2008 EC (Acute tox category 4) and there may be the potential for short term peak inhalation exposures for workers. Protective measures applied to ensure that exposures are below the DNEL for long term exposure will also ensure protection from acute exposure. (TGD R8.1.2.5) Dose descriptor In an acute inhalation study in the rat a LC50 of 8.3 mg/L = 8300 mg/m3 for a 1 hour exposure was identified (SIDS 1982). The LC1 of 580 mg/m3 was calculated by the authors and this is the basis for deriving the DNEL since it is the most sensitive starting point. Another acute inhalation study identified a LC100 of 4470 mg/m3 for a 4 hour exposure (FMC, 1980).

It is proposed to use the LC1 of 580 mg/m3 to derive the DNEL since the appropriate LC50 has been estimated. Modification of dose descriptor Since the LC1 value is from a 1 hour exposure it is considered acceptable not to use a time scaling factor to adjust it to the time recommended for peak exposure (15 minutes) (Guidance on the application of CLP criteria section 3.1 acute toxicity). The derived LC1 is therefore estimated to be 580 mg/m3. No adjustment for time differences in exposure is necessary Corrected LC1inhalation = LC1 x [ABSinhal-rat/ABSinhal-human] x [sRVhuman/wRV] = 580 x [100/100] x [6.7/10] = 389 mg/m3 worker DNEL acute inhal = 389 mg/m3/62.5 = 6.22 mg/m3

AF for dose response relationship:
5
Justification:
Default AF. Clear NOAEL is not identified. Endpoint was lethality. An extra assessment factor has therefore been used
AF for interspecies differences (allometric scaling):
1
Justification:
ECHA REACH Guidance (Effects not dependent on metabolic rate)
AF for other interspecies differences:
2.5
Justification:
ECHA REACH Guidance (Default AF for systemic effects)
AF for intraspecies differences:
5
Justification:
ECHA REACH Guidance (Default AF for workers)
AF for the quality of the whole database:
1
Justification:
ECHA REACH Guidance (Default AF for good quality data)
AF for remaining uncertainties:
1
Justification:
Differences in duration of exposure. Default AF. 1 hour exposure is considered to be protective of peak exposure duration of 15 minutes

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.5 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Dose descriptor starting point:
NOAEL
Value:
50 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
50 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

DN(M)EL related information A DNEL has been derived (adjusted for route-route differences) according to ECHA guidance from oral subchronic repeated dose toxicity data.

AF for dose response relationship:
1
Justification:
ECHA REACH Guidance (Clear NOAEL with no uncertainties in the dose descriptor)
AF for differences in duration of exposure:
2
Justification:
ECHA REACH Guidance (Subchronic to chronic AF)
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA REACH Guidance (Default AF for rat-human)
AF for other interspecies differences:
2.5
Justification:
ECHA REACH Guidance (Default AF for systemic effects)
AF for intraspecies differences:
5
Justification:
ECHA REACH Guidance (Default AF for workers)
AF for the quality of the whole database:
1
Justification:
ECHA REACH Guidance (Default AF)
AF for remaining uncertainties:
0
Justification:
ECHA REACH Guidance
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
20 µg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
50
Dose descriptor:
other: EC3 [μg/cm2] considered LOAEL for induction
AF for dose response relationship:
4
Justification:
Clear DR curve to extrapolate EC3. ECHA recommends AF of 3-10 for LOAEL as the point of departure. AF of 4 selected to account for shallow slope of the DR curve and spacing of doses at 10-fold intervals (0.5, 5 and 50 % (w/v) in acetone/olive oil (4:1). ECHA and ECETOC guidance detail a starting AF of 3 when the LOAEL is the point of departure.
AF for differences in duration of exposure:
1
Justification:
Default AF for local effects. The potential for accumulation is considered low due to de-esterification of DAP and DAIP by skin esterases and the subsequent clearance of metabolites, phthalic acid and allyl alcohol.
AF for interspecies differences (allometric scaling):
1
Justification:
ECHA REACH Guidance (Default AF for local effects)
AF for other interspecies differences:
2.5
Justification:
Default value of 2.5 entered for local effects on the skin via local metabolism. ECHA requires default values to be used in the absence of relevant substance specific info (which is not available). Default AF of 2.5 entered to allow for the difference in esterase activity between the mouse and human.
AF for intraspecies differences:
5
Justification:
ECHA guidance (Default AF for workers)
AF for the quality of the whole database:
1
Justification:
ECHA guidance (Default AF)
AF for remaining uncertainties:
1
Justification:
ECHA REACH Guidance
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
20 µg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
50
Dose descriptor starting point:
other: EC3 [μg/cm2] considered LOAEL for induction
AF for dose response relationship:
4
Justification:
Clear DR curve to extrapolate EC3. ECHA recommends AF of 3-10 for LOAEL as the point of departure. AF of 4 selected to account for shallow slope of the DR curve and spacing of doses at 10-fold intervals (0.5, 5 and 50 % (w/v) in acetone/olive oil (4:1). ECHA and ECETOC guidance detail a starting AF of 3 when the LOAEL is the point of departure.
AF for interspecies differences (allometric scaling):
1
Justification:
Default AF for local effects. The potential for accumulation is considered low due to efficiency of removal by enzyme esterification within the skin and the effective clearance of metabolites, phthalic acid and allyl alcohol.
AF for other interspecies differences:
2.5
Justification:
Default value of 2.5 entered for local effects on the skin via local metabolism. ECHA requires default values to be used in the absence of relevant substance specific info (which is not available). Default AF of 2.5 entered to allow for the difference in esterase activity between the mouse and human.
AF for intraspecies differences:
5
Justification:
ECHA guidance (Default AF for workers)
AF for the quality of the whole database:
1
Justification:
ECHA REACH Guidance (Default AF)
AF for remaining uncertainties:
0
Justification:
ECHA REACH Guidance

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

Discussion for workers

The information used to derive DNELs has been obtained via testing on DAP, a closely related structural analogue for DAIP. DAIP has a slightly higher vapour pressure than DAP (0.15 Pa rather than 0.0213 Pa). DAP (and therefore DAIP) is not classified as an eye irritant , therefore there is no hazard associated with this endpoint. Although DAP (and therefore DAIP is not classified as a skin irritant DAP and therefore DAIP are classified as a skin sensitiser.

 Correlation between dose and response was observed within the study and allowed for calculation of an EC3 value, which allowed for derivation of a DNEL. A quantitative risk assessment has been carried out to cover local hazards via the dermal route and the use of appropriate gloves and LEV is recommended for tasks where exposure may arise. A quantitative risk assessment has been carried out to cover local hazards via the dermal route. The DNEL for acute local dermal hazard is not required since the short term exposure conditions are controlled by the long term exposure conditions. There are no specific studies on local inhalation hazard and it is difficult to identify local effects from the available information which is confined to acute inhalation toxicity studies where the endpoint was lethality, however, there was no indication of specific local irritation from these studies. In addition, the control measures put in place for long term systemic exposure should prevent local effects occurring in workers. Therefore although the specific hazard is unknown, no further information is required. Acute systemic inhalation exposure is considered to be a slim possibility at peak exposures, and DAP and therefore DAIP is classified as an acute inhalation hazard (cat 4) hence a DNEL has been derived (6.22 mg/m3), however, the control measures put in place for long term systemic exposure via the inhalation route should prevent acute effects occurring in workers. In addition the low vapour pressure should limit the potential for significant exposure.

The critical DNELs were found to be long term systemic exposure, 3.52 mg/m3 (inhalation) or 0.5 mg/kg/day (dermal). The DNELs were derived from oral subchronic and carcinogenicity studies where the NOAEL for adverse hepatocellular effects was 50 mg/kg/day. A combined fertility and developmental toxicity study was conducted according to OECD 421 which corroborated this dose descriptor selection for adults but no effects were observed on F1 animals at the highest dose of 150 mg/kg/day. In an embryofetal/teratogenicity study (OECD 414) the results were supportive of the previous reproductive study and a NOAEL of 150 mg/kg/day for fetal skeletal variations and reduced litter weights. Therefore the NOAEL of 50 mg/kg/day is supported by several animal studies and is considered to be robust and the critical endpoint. 

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.44 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Dose descriptor starting point:
NOAEL
Value:
50 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
43.5 mg/m³
Explanation for the modification of the dose descriptor starting point:

There were no systemic long term inhalation study data. The data are taken from a 13 weeks 5 days/week oral gavage study (NTP 1985) in which hepatocellular periportal necrosis, fibrosis, cirrhosis and bile duct hyperplasia were present. The NOAEL was identified at 50 mg/kg/day. Conversion of rat oral NOAEL from 90 day study to is required. Significant exposure via the inhalation route is considered to be unlikely since the vapour pressure of DAIP, like that of DAP is relatively low.

Modification of dose descriptor:

Convert the rat oral NOAEL into a human inhalation NOAEC (mg/m3) after adjusting for differences in up take between the two routes using a default factor of 1 (100% oral/100% inhalation). Oral absorption of diallylphthalate is extensive (Eigenberg et al 1986) so assumption of 100% oral absorption and 100% inhalation for both rats and humans is appropriate. CorrectedNOAECinhalation = Oral NOAEL x [1/ sRVrat1] x [ABSoral-rat/ABSinhal-human] x[ABSinhal-rat/ABSinhal-human] CorrectedNOAECinhalation = 50 x [1/1.15] x [100/100] x [100/100] = 43.5 mg/m3.

Study design in accordance with generally accepted scientific standards and described in sufficient detail. However, 5 day per week dosing design is less relevant to the general population so a factor of 2 added.

Overall AF 100 General populationDNELlong-term inhal = 43.5 mg/m3/100 = 0.44 mg/m3

AF for dose response relationship:
1
Justification:
ECHA REACH Guidance (Clear NOAEL with no uncertainties in the dose descriptor)
AF for differences in duration of exposure:
2
Justification:
ECHA REACH Guidance (Subchronic to chronic AF)
AF for interspecies differences (allometric scaling):
1
Justification:
ECHA REACH Guidance (Effects not dependent on metabolic rate)
AF for other interspecies differences:
2.5
Justification:
ECHA REACH Guidance (Default AF for systemic effects)
AF for intraspecies differences:
10
Justification:
ECHA REACH Guidance (Default AF for general population)
AF for the quality of the whole database:
2
Justification:
ECHA REACH Guidance (AF of 2 added to cover potential longer exposure to the general population)
AF for remaining uncertainties:
0
Justification:
ECHA REACH Guidance
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4.64 mg/m³
Most sensitive endpoint:
acute toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
125
Modified dose descriptor starting point:
other: LC 1
Value:
580 mg/m³
AF for dose response relationship:
5
Justification:
ECHA REACH Guidance. No clear NOAEL identified. LC1 of 0.58 mg/m3 used. Additional AF added
AF for interspecies differences (allometric scaling):
1
Justification:
ECHA REACH Guidance (Effects not dependent on metabolic rate)
AF for other interspecies differences:
2.5
Justification:
ECHA REACH Guidance (Default AF for systemic effects)
AF for intraspecies differences:
10
Justification:
ECHA REACH Guidance (Default AF for general population)
AF for the quality of the whole database:
1
Justification:
ECHA REACH Guidance.
AF for remaining uncertainties:
0
Justification:
Study design in accordance with generally accepted scientific standards and described in sufficient detail.

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.12 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
400
Dose descriptor starting point:
NOAEL
Value:
50 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
50 mg/kg bw/day
AF for dose response relationship:
1
Justification:
ECHA Guidance document details when the point of departure is a NOAEL the default AF is 1. As a clear NOAEL was selected from a repeated dose study an AF of 1 was assigned as there were no uncertainties in the dose descriptor.
AF for differences in duration of exposure:
2
Justification:
ECHA guidance (Sub-chronic to chronic AF).
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA guidance. Default AF of 4 added to extrapolate dose from experimental animals to humans based on relative differences in basal metabolic rate.
AF for other interspecies differences:
2.5
Justification:
ECHA guidance. Default AF for remaining differences for systemic effects.
AF for intraspecies differences:
10
Justification:
ECHA guidance. Default AF of 10 assigned. This is considered a sufficient AF to protect the larger part of the general population.
AF for the quality of the whole database:
2
Justification:
ECHA guidance (p30)
Although the study is of good/standard quality there is a deficiency in extrapolation to the general population for 7-day exposure. An AF of 2 has therefore been assigned to account for the potential of 7-day exposure and accumulation to the general population over an extended period.
AF for remaining uncertainties:
0
Justification:
ECHA guidance
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
10 µg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Dose descriptor:
other: EC3 [μg/cm2], LOAEL for induction
Value:
1 000 µg/m³
AF for dose response relationship:
4
Justification:
Clear DR curve to extrapolate EC3. ECHA recommends AF of 3-10 for LOAEL as the point of departure. AF of 3 selected for local long-term effects to account for shallow slope of the DR curve and spacing of doses at 10-fold intervals (0.5, 5 and 50 % (w/v) in acetone/olive oil (4:1). ECHA and ECETOC guidance detail a starting AF of 3 when the LOAEL is the point of departure.
AF for differences in duration of exposure:
1
Justification:
Default AF for local effects. The potential for accumulation is considered low due to de-esterification of DAP and DAIP by skin esterases and the subsequent clearance of metabolites, phthalic acid and allyl alcohol.
AF for interspecies differences (allometric scaling):
1
Justification:
Default AF for local effects. The potential for accumulation is considered low due to efficiency of removal by enzyme esterification within the skin and the effective clearance of metabolites, phthalic acid and allyl alcohol.
AF for other interspecies differences:
2.5
Justification:
Default value of 2.5 entered for local effects on the skin via local metabolism. ECHA requires default values to be used in the absence of relevant substance specific info (which is not available). Default AF of 2.5 entered to allow for the difference in esterase activity between the mouse and human.
AF for intraspecies differences:
10
Justification:
ECHA guidance (Default AF for general population)
AF for the quality of the whole database:
1
Justification:
ECHA guidance (Default AF)
AF for remaining uncertainties:
0
Justification:
ECHA guidance
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
10 µg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Dose descriptor starting point:
other: EC3 [μg/cm2], LOAEL for induction
Value:
1 000 µg/m³
AF for dose response relationship:
4
Justification:
Clear DR curve to extrapolate EC3. ECHA recommends AF of 3-10 for LOAEL as the point of departure. AF of 3 selected for local long-term effects to account for shallow slope of the DR curve and spacing of doses at 10-fold intervals (0.5, 5 and 50 % (w/v) in acetone/olive oil (4:1). ECHA and ECETOC guidance detail a starting AF of 3 when the LOAEL is the point of departure.
AF for interspecies differences (allometric scaling):
1
Justification:
Default AF for local effects. The potential for accumulation is considered low due to efficiency of removal by enzyme esterification of DAP and DAIP within the skin and the effective clearance of metabolites, phthalic acid and allyl alcohol.
AF for other interspecies differences:
2.5
Justification:
Default value of 2.5 entered for local effects on the skin via local metabolism. ECHA requires default values to be used in the absence of relevant substance specific info (which is not available). Default AF of 2.5 entered to allow for the difference in esterase activity between the mouse and human.
AF for intraspecies differences:
10
Justification:
ECHA guidance (Default AF for general population)
AF for the quality of the whole database:
1
Justification:
ECHA guidance (Default AF)
AF for remaining uncertainties:
1
Justification:
No AF entered for remaining uncertainties as we do not consider substance accumulation will arise and present an increased risk for skin sensitisation.

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.13 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
400
Dose descriptor starting point:
NOAEL
Value:
50 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
50 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The data are taken from a 13 weeks 5 days/week oral gavage study (NTP 1985) in which hepatocellular periportal necrosis, fibrosis, cirrhosis and bile duct hyperplasia were present. The NOAEL was identified at 50 mg/kg/day. Two chronic 2 year studies have been conducted.  The NOAEL for the studies was 50 mg/kg/day (NTP, 1985). 

AF for dose response relationship:
1
Justification:
ECHA guidance (Clear NOAEL with no uncertainties in the dose descriptor)
AF for differences in duration of exposure:
2
Justification:
ECHA guidance (Subchronic to chronic AF)
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA guidance (Default AF for rats-human)
AF for other interspecies differences:
2.5
Justification:
ECHA guidance (Default AF for systemic effects)
AF for intraspecies differences:
10
Justification:
ECHA guidance (Default AF for general population)
AF for the quality of the whole database:
2
Justification:
Study design in accordance with generally accepted scientific standards and described in sufficient detail. However, 5 day per week dosing design is less relevant to the general population so a factor of 2 added
AF for remaining uncertainties:
0
Justification:
ECHA guidance
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

Data for dermal exposure and exposure by inhalation are limited to acute toxicity tests. For dermal exposure, the dose descriptors are not unequivocally reliable. The key study shows an LD50 of 3300 mg/kg bw, but 30% mortality was recorded at a dose level of 200 mg/kg bw. Although other references more or less confirm the LD50 of 3300 mg/kg bw, most of these data originate from secondary sources. Hence, the only source for calculating the Derived Minimum Effect Level (DMEL) was this dose level of 200 mg/kg bw. As discussed for this study, the three rabbits that died at this level, died on the first day of exposure, whereas only one rabbit had died at each of the other dose levels, which were a magnitude higher. As no data were provided on treatment controls, the results could not be verified. For these reasons, the DMELs calculated here should be taken as an indicative value, rather than a workable value for hazard assessment. However, when comparing these DMELs with the DNEL for oral toxicity, they are within the same range. Comparison with the DNELs for inhalation is not possible due to the difference in expression of the descriptive values.