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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:
Feb/Mar 1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Guideline study. No GLP compliance is claimed, however, the final report includes an audit and quality assurance inspections. The study was conducted using skin that had been abraded (care was taken so as to only penetrate the stratum corneum and not the dermis). This deviates from the current OECD Guideline 402, however, this is not considered to affect the outcome of the study as the test material resulted in an LD50 of > 2000 mg/kg.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
This study was conducted using skin that had been abraded (care was taken so as to only penetrate the stratum corneum and not the dermis). However, this will not affect the outcome of the study.
GLP compliance:
no
Remarks:
The final report includes an audit and quality assurance inspections.
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
- Storage condition of test material: room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.0 to 2.4 kg
- Fasting period before study: No
- Housing: Individually housed in stainless steel cages (61.0 x 45.5 x 42.0 cm)
- Diet: Rabbits were fed Purina Rabbit Chow Complete Blend (Ralston Purina Co.) ad libitum
- Water: ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): approx. 22
- Humidity (%): approx. 40 (relative)
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES:
From 19 February 1981 to 6 March 1981

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: An area of 240 cm2 on the back of each animal
- Type of wrap if used: gauze pad and plastic film covered by towelling

REMOVAL OF TEST SUBSTANCE
- Washing (if done): skin washed clean of excess test material (solvent not reported)
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg
- Concentration (if solution): applied undiluted
- Constant volume or concentration used: yes
Duration of exposure:
24 h
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 male and 5 female
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations were performed at least once a day; animals were weighed immediately prior to dosing
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Statistics:
No statistical methods used.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortalities occured during the study.
Clinical signs:
One male rabbit had diarrhoea on days 2, 3 and 4, as did one female rabbit on day 3. This female and a different male rabbit had diarrhoea (immediately prior to dosing). All rabbits appeared normal on day 5 and for the remainder of the observation period. Therefore this finding probably is not treatment related.
Body weight:
2.0 - 2.4 kg at study initiation
Gross pathology:
No abnormal findings noted.
Other findings:
No other findings are reported.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
The test report describes a valid guideline study, with auditation and quality assurance inspections of the final report. The acute dermal LD50 was determined to be greater than 2000 mg/kg. Thus, the test substance can be considered as not acutely toxic via the dermal route.
Executive summary:

An acute dermal study was conducted using a similar procedure to that described in the current OECD Guideline 402 (Reckers, 1981). The test material (CAS No. 91648-65-6) was applied at a dose of 2000 mg/kg to the backs of five male and five female rabbits. The test item was left in contact with the skin for 24 hours and then the test sites were washed and the rabbits observed during this time and for 14 days after its removal. One male rabbit had diarrhea on days 2, 3 and 4, as did one female rabbit on day 3. This female and a different male rabbit had diarrhea (immediately prior to dosing). All rabbits appeared normal on day 5 and for the remainder of the observation period. Therefore this finding probably is not treatment related. There were no mortalities during the study and gross necropsy findings in all rabbits were within normal limits. The acute dermal LD50 was determined to be greater than 2000 mg/kg.