2-Propenamide, N-(2-hydroxyethyl)-

Endpoint summary

Description of key information

Acute oral:

The acute lethal oral dose to rats of HEAA was demonstrated to be greater than 2000 mg/kg bodyweight.

Acute dermal:

The acute lethal oral dose to rats of HEAA was demonstrated to be greater than 2000 mg/kg bodyweight.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

31 May 2000 to 30 June 2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Specific details on test material used for the study:

Lot number: MDB-329
Purity: >99%

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan UK Ltd., Bicester, Oxon, England.
- Age at study initiation: 5 to 7 weeks
- Weight at study initiation: 94 to 108 g.
- Fasting period before study: Access to food was only prevented overnight prior to and for approximately 4 hours after dosing.
- Housing: The rats were housed in groups of three, of the same sex, in metal cages. The cages were fitted with grid floors to ensure rapid removal of waste material to undertrays.
- Diet: Special diet services RMI E; SQC expanded pellet, ad libitum
- Water: ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 30 - 70%
- Air changes (per hr):
- Photoperiod: 12 hrs dark / 12 hrs light

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg

Doses:

300 and 2000 mg/kg

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: Animals were observed immediately after dosing and at approximately hourly intervals for the remainder of Day 1. On subsequent days animals were observed once in the morning and again at the end of the day.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopic pathology.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

None

Clinical signs:

other: Clinical signs were confined to piloerection, notable in all rats at both dosages. There were no signs of response to treatment and piloerection had resolved in all instances within 48 hours of dosing.

Gross pathology:

No abnormalities were revealed at the macroscopic examination.

Interpretation of results:

GHS criteria not met

Conclusions:

The acute lethal oral dose to rats of HEAA was demonstrated to be greater than 2000 mg/kg bodyweight.

Executive summary:

The study was performed to assess the acute oral toxicity of HEAA to rat, according to OECD Guideline 423, under GLP.

The acute lethal oral dose to rats of HEAA was demonstrated to be greater than 2000 mg/kg bodyweight.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

> 2 000 mg/kg bw

Quality of whole database:

reliable without restrictions

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

23 May 2006 to 8 June 2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: Japanese Ministry of Agriculture, Forestry and Fisheries, Test Data for Registration of Agricultural Chemicals, Acute dermal toxicity (2-1-2), 12 Nohsan No. 8147, Agricultural Production Bureau, November 24, 2000.

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Specific details on test material used for the study:

Lot number: 050804
Purity: >99%

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River U.K. Ltd., Margate, Kent, England.
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: 232 to 450g
- Fasting period before study:
- Housing:They were housed individually from Day -1 in metal cages (RS Biotech Cages - polished stainless steel) until Day 6 when they were returned to group housing. The cages were fitted with grid floors to ensure rapid removal of waste material to undertrays. The cages were suspended in mobile stainless steel racks.
- Diet : A standard laboratory rodent diet (Special Diet Services RM1(E) SQC expanded pellet), ad libitum
- Water:ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 23°C
- Humidity (%): 40 - 70%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): Lighting was controlled by means of a time switch to provide 12 hours of artificial light (0600 - 1800 hours GMT) in each 24-hour period.

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 50 mm x 50 mm
- % coverage: 100%
- Type of wrap if used: The treatment area (approximately 50 mm x 50 mm) was covered with porous gauze held in place with a non-irritating dressing, and further covered by a waterproof dressing encircled firmly around the trunk of the animal.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated area of skin was washed with warm water (30 - 40°C), to remove any residual test substance.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg / kg bw.

Duration of exposure:

24 hours

Doses:

2000 mg/kg

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed soon after dosing and at frequent intervals for the remainder of Day 1. On subsequent days animals were observed once in the morning and again at the end of the experimental day (with the exception of Day 15 - morning only). The bodyweight of each rat was recorded on Days 1 (prior to dosing), 8 and 15. Individual weekly
bodyweight changes and group mean bodyweights were calculated.

- Necropsy of survivors performed: yes

- Other examinations performed: mortality,clinical signs, dermal responses, body weight, macroscopic pathology.

Preliminary study:

None

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths and no systemic response to treatment in any animal.

Clinical signs:

other: None

Gross pathology:

No abnormalities were noted in any animal at the macroscopic examination at study termination on Day 15.

Interpretation of results:

GHS criteria not met

Conclusions:

The acute lethal dermal dose to rats of HEAA was demonstrated to be greater than 2000 mg/kg bodyweight.

Executive summary:

The study was performed to assess the acute dermal toxicity of HEAA to the rat, according to OECD Guideline 402, under GLP.

The acute lethal dermal dose to rats of HEAA was demonstrated to be greater than 2000 mg/kg bodyweight.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

> 2 000 mg/kg bw

Quality of whole database:

reliable without restrictions

Additional information

Acute oral:

The study was performed to assess the acute oral toxicity of HEAA to rat, according to OECD Guideline 423, under GLP.

The acute lethal oral dose to rats of HEAA was demonstrated to be greater than 2000 mg/kg bodyweight.

Acute dermal:

The study was performed to assess the acute dermal toxicity of HEAA to the rat, according to OECD Guideline 402, under GLP.

The acute lethal dermal dose to rats of HEAA was demonstrated to be greater than 2000 mg/kg bodyweight.

Justification for classification or non-classification

Acute toxicity:

Oral, OECD 423: LD50 > 2000 mg/kg bodyweight

Dermal, OECD 402: LD50 > 2000 mg/kg bodyweight

Therefore in accordance with Regulation (EC) No. 1272/2008 (amended by 286/2011) Table 3.1.1 , this substance should not be classified.

 

Specific target organ toxicity-single exposure:

Necropsy: No abnormalities were noted at necropsy in both oral and dermal studies.

As there were no effects considered to support classification for Category 1 and 2 observed. Therefore in accordance with Regulation (EC) No. 1272/2008 Table 3.8.1 and 3.8.2, this substance should not be classified.