Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented, according to accepted guidelines.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
-reliability scoring based on 1987 guideline
Deviations:
yes
Remarks:
-insignificant deviation, guideline suggests using animals of all the same sex
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Secondary Butyl Alcohol
- Physical state: colourless, clear liquid
- Analytical purity: 99.5%
- Expiration date of the lot/batch: one calendar month from the date of issue
- Lot/batch No.: Indent 9200/9530
- Stability under test conditions: Test substance was judged to have been stable for the duration of this study.
- Storage condition of test material: Following its arrival in compound control this test substance was stored in the dark at ambient temperature.

Test animals

Species:
rat
Strain:
Fischer 344
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River U.K. Ltd.
- Age at study initiation: 9 to 11 weeks old
- Weight at study initiation: Weight on Day 1 = 227 to 265 g (males) and 153 to 170 g (females)
- Fasting period before study: Fasted overnight (18 h) prior to dosing.
- Housing: Two days before dosing, the rats to be used were housed in groups of 2 or 3 animals of the same sex per cage.
- Diet (e.g. ad libitum): Food (PRD, Labsure Animal Foods, Dorset), ad libitum; however, food was withheld 24 hours after administration
- Water (e.g. ad libitum): Filtered but untreated water from the public supply, ad libitum
- Acclimation period: not reported


ENVIRONMENTAL CONDITIONS
- Temperature (°C): air temperature was 19 to 25 °C
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsal
- % coverage: not reported
- Type of wrap if used: The test material was covered with a piece of aluminum foil which was held in place by a double over-wrap of waterproof adhesive tape.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the exposure period, the tape and foil were carefully removed and the skin was washed with warm dilute detergent solution and then dried.
- Time after start of exposure: 24 hrs


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): not reported
- Concentration (if solution): undiluted
- Constant volume or concentration used: not applicable
- For solids, paste formed: not applicable
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 animals/sex
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for signs of toxicity for 14 days after dosing. Body weights were recorded on Days 1, 7, and 14.
- Necropsy of survivors performed: No
- Other examinations performed: clinical signs and body weight
Statistics:
Statistical analysis was not performed, but is not required.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: The LD50 value was not determined since none of the rats died at a dose level of 2000 mg/kg bw. The LD50 value was predicted to be greater than 2000 mg/kg bw.
Mortality:
None of the rats died over a period of 14 days.
Clinical signs:
There were no clinical signs seen.
Body weight:
All rats had gained weight relative to their day 1 body weights by the end of the 14-day observation period.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP (EC 1272/2008)