Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study was selected as the key study because the information provided for the hazard endpoint is sufficient for the purpose of classification and labelling and/or risk assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
2 males were dosed (instead of the required 5/sex); 5000 mg/kg bw was used instead of 2000 mg/kg bw; no pathology was performed.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Purity: 99.9%

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: Not reported
- Weight at study initiation: 2525 and 2502 g
- Fasting period before study: No
- Housing: Singly in suspended, stainless steel, wire-mesh cages
- Diet (e.g. ad libitum): 125 g rabbit chow daily
- Water (e.g. ad libitum): ad libitum
- Acclimation period: Approximately 2 weeks


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±1°C
- Humidity (%): 50±10%
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12-hour light/12-hour dark

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: approximately 190 cm2
- % coverage: 190 cm2 is equal to approximately 10% of the total body surface area of rabbits in the 2-3 kg body weight range
- Type of wrap if used: The test substance was covered with a 2-ply gauze patch. The rabbit was wrapped with successive layers of plastic film, stretch gauze bandage, and elastic adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Excess test substance was washed from the animals' backs with warm water and the skin was dried with a paper towel.
- Time after start of exposure: approximately 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5000 mg/kg
- Concentration (if solution): undiluted
Duration of exposure:
24 hours
Doses:
5000 mg/kg
No. of animals per sex per dose:
2 males
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: Observations for mortality were made daily throughout the study. Approximately 1 hour after test substance removal, the rabbits were observed for clinical signs of toxicity and dermal irritation. Observations for clinical signs and other dermal effects were made daily for 14 days after treatment (excluding weekends).
- Frequency of weighing: On the day of dosing and on days 1, 7, and 14 following treatment
- Necropsy of survivors performed: No

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Remarks on result:
other: Adverse Effects: No clinical signs of toxicity; slight dermal irritation in 1 rabbit, but not the other.
Mortality:
No mortality was observed.
Clinical signs:
No clinical signs of toxicity were observed.

Applicant's summary and conclusion

Interpretation of results:
other: at worst, slightly toxic
Remarks:
Criteria used for interpretation of results: expert judgment
Conclusions:
The study and the conclusions which are drawn from it fulfil the quality criteria (validity, reliability, repeatability).

LD50 > 5000 mg/kg
Executive summary:

The test substance was applied to the shaved, intact skin of 2 male New Zealand White rabbits at a dosage of 5000 mg/kg. The application site was occluded for approximately 24 hours after which the test substance was removed. The rabbits were observed for clinical signs of toxicity and dermal effects for 14 days following removal of the test substance (weekends excluded). No deaths occurred, and no clinical signs of toxicity were observed in either rabbit. The test substance produced slight erythema 1 and 2 days after application in one rabbit. No irritation was observed in the second rabbit. Under the conditions of this test, the ALD was >5000 mg/kg of body weight.