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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
Study period:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study without detailed documentation.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
-body weights not reported, and gross pathologic examinations were conducted but no data was presented in report
GLP compliance:
no
Remarks:
Study pre-dates GLP
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): diacetone alcohol (DAA)
- Physical state: Stated in the report as a "widely used solvent"
- Analytical purity: Not reported
- Lot/batch No.: Reference PER 47657/2
- Expiration date of the lot/batch: Not reported
- Stability under test conditions: Not reported

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Shell Toxicology Laboraotry (Tunstall) Breeding Unit
- Age at study initiation: Approximately 10 weeks
- Weight at study initiation: Not reported
- Fasting period before study: Not reported
- Housing: Four animals/sex were housed in each cage.
- Diet (e.g. ad libitum): Rat food (PRD, Labsure Animal Foods Ltd.), ad libitum; however, during the 24 hr exposure period, food was withheld
- Water (e.g. ad libitum): Filtered but untreated water from the public supply, provided by means of water bottles refilled every other day
- Acclimation period: Not reported

ENVIRONMENTAL CONDITIONS
- Temperature (°C): room temperature, 22 ± 2
- Humidity (%): 55 ± 5
- Air changes (per hr): 15
- 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 substance was covered with a piece of aluminium foil and held in place by a double overwrap of waterproof adhesive tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The foil and plaster dressing was carefully removed and the skin was washed with warm dilute detergent solution and then dried.
- Time after start of exposure: at the end of the 24 hr exposure period

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 mL/kg body weight
- Concentration (if solution): undiluted
- Constant volume or concentration used: yes
Duration of exposure:
24 hours
Doses:
2 mL/kg body weight (1875 mg/kg body weight)
No. of animals per sex per dose:
6 animals/sex
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 or 21 days
- Frequency of observations and weighing: Body weights were recorded initially, Day 7, and on Day 14.
- Necropsy of survivors performed: yes
- Other examinations performed: Animals were observed for signs of toxicity over 14 or 21 days.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 1 875 mg/kg bw
Mortality:
The application of undiluted chemical for 24 hours to groups of 6 male and 6 female rats did not result in any mortalities at a dose level of 2 mL/kg body weight, the largest volume that could be applied to the skin.
Clinical signs:
Rats showed no toxic signs.
Body weight:
Results were not reported.
Gross pathology:
Results were not reported.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP (EC 1272/2008)
Conclusions:
The acute (24 h) percutaneous LD50 of the test material in rats was greater than 2 mL/kg body weight, the largest volume that could be applied to the skin (equivalent to greater than 1875 mg/kg body weight).
Executive summary:

The potential acute dermal toxicity of diacetone alcohol was assessed in Wistar rats in a study similar in methodology to OECD Guidelines for the Testing of Chemicals No. 402 (Cassidy and Blair, 1978). Undiluted diacetone alcohol was applied for 24 hours to 6 male and 6 female rats at 2 mL/kg body weight (equivalent to 1875 mg/kg body weight) for 24 hours. The test substance was applied to the shaved dorsal skin of the animals andcovered with a piece of aluminium foil held in place by a double overwrap of waterproof adhesive tape. After 24 hours, the foil and plastic dressing were removed, and the skin was washed with warm dilute detergent and dried. The animals were observed for signs of toxicity for 14 or 21 days and necropsy was performed. There were no reactions or clinical signs of toxicity, and the dermal LD0 of diacetone alcohol was reported to be greater than 2 mL/kg body weight (equivalent to 1875 mg/kg body weight).