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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant, guideline study, available as unpublished report, minor restrictions in reporting but otherwise adequate for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OTS 798.1100 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
occlusive dressing used
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Naphtha (petroleum), steam-cracked middle arom.
EC Number:
271-138-9
EC Name:
Naphtha (petroleum), steam-cracked middle arom.
Cas Number:
68516-20-1
IUPAC Name:
68516-20-1
Constituent 2
Reference substance name:
E000144700
IUPAC Name:
E000144700
Details on test material:
- Name of test material (as cited in study report): E000144700
- Physical state: Clear, pale yellow to yellow liquid, gasoline-like naphtha odour
- Analytical purity: Not reported
- Lot/batch No.: Not reported
- Stability under test conditions: Stable
- Storage condition of test material: 50-80°F

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Camm Research, Wayne, New Jersey, USA
- Sex: 5 males and 5 females
- Age at study initiation: Young adult
- Weight at study initiation: Approximately 2.0-3.0 kg.
- Housing: Individually in stainless steel, wire mesh bottom cages
- Diet: Agway rabbit food ad libitum
- Water: ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature: 61-70°F
- Humidity: 40-60%
- Air changes: At least 10/hour
- Photoperiod: 12 hrs dark / 12 hrs light
IN-LIFE DATES: From: 6 March 1990 To: 20 March 1990

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsal (size of application area not reported)
- Type of wrap if used: Occlusive (no further details reported)

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg
- Constant volume or concentration used: yes (Individual dose volumes were adjusted based on the density (0.9145 g/mL) and the animal's bodyweight).
Duration of exposure:
24 h
Doses:
2000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of weighing: On arrival, the day of dosing, week 1 and at termination
- Clinical observations made hourly for first 4 hours after dosing, and twice (a.m. and p.m.) for the following 13 days.
- Necropsy of survivors performed: yes
Statistics:
Not required

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: no mortality or evidence of systemic toxicity at only dose tested
Mortality:
No mortalities.
Clinical signs:
All animals on study exhibited one or more of following: oedema, erythema, eschar and dried skin at test site, abnormal stools.
Body weight:
All animals gained weight during the study.
Gross pathology:
All animals exhibited one or more of following: oedema, erythema, eschar and dried skin at test site.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal LD50 for E000144700 is greater than 2000 mg/kg.
Executive summary:

The acute dermal toxicity of E000144700 (CAS 68516-20-1) was assessed in a group of 5 male and 5 female albino rabbits. The test substance was applied at 2000 mg/kg under an occlusive dressing for 24 hours. None of the animals died and there were no significant signs of systemic toxicity.

The acute dermal LD50 for E000144700 (CAS 68516-20-1) is greater than 2000 mg/kg and no classification is warranted under Dir 67/548/EEC or under GHS/CLP.