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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study meets generally accepted scientific principles, acceptable for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
Only 3 animals per sex versus 5 as per guideline
Qualifier:
equivalent or similar to guideline
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
Only 3 animals per sex versus 5 as per guideline
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
2,2,4-trimethylpentane
EC Number:
208-759-1
EC Name:
2,2,4-trimethylpentane
Cas Number:
540-84-1
IUPAC Name:
2,2,4-trimethylpentane
Details on test material:
- Name of test material (as cited in study report): Isooctane
- Analytical purity: 100% pure commercial product

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female

Administration / exposure

Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observation continuous, weighing on initiation and days 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, dermal score

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality occurred during the 14-day observation period.
Clinical signs:
other: All rabbits appeared normal throughout the study. Very slight dermal erythema was noted in all animals on day 1 after dosing, which persisted in one male and one female on day 3. All erythema had cleared by day 7. Very slight edema was noted in two males
Gross pathology:
No abnormal gross pathology was noted in any rabbits upon necropsy.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: GHS, EU, 2007
Conclusions:
Based on the study design the test substance, Isooctane, needs not to be classified.
Executive summary:

Based on the study design the substance, Isooctane, needs not to be classified.