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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:
1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hazleton Research Products, Inc. Denver, Pennsylvania
- Age at study initiation: 11 weeks
- Weight at study initiation: 2014 - 2224g
- Housing: singly
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 6d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22
- Humidity (%): 64-82
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsal skin
- % coverage: 18-20
- Type of wrap if used: gauze binders that were secured with Derrniforme" tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): sites wiped with wet disposable paper towels moistened with tepid tap wate
- Time after start of exposure: 24h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- For solids, paste formed: no
Duration of exposure:
24h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: rabbits were observed at approximately 1.0, 3.0 and 4.0 hours post-dose on day 0 and once daily thereafter for 14 days, body weights were obtained and recorded on study days 0 (initiation), 7 and 14 (study termination).
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, dermal observations

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
There were no deaths during the study.
Clinical signs:
Five rabbits had abnormal defecation (soft stool, mucoid feces) on day 0 or 1. One of these animals also had wet, and subsequently, dry brown urogenital matting. These findings were considered to be a result of the bandaging / restraint procedures used and not related to the test material. An additional spontaneous occurrence of soft stool was noted on day 9 for one animal. There were no other clinical findings.
Body weight:
There were no remarkable changes or differences noted in body weights during the study.
Gross pathology:
Accessory splenic tissue, a common congenital abnormality in this strain of rabbit, was noted for four animals at the terminal necropsy. There were no other gross necropsy findings for all examined tissues.
Other findings:
The test material induced generally very slight to slight erythema on all rabbits and very slight to slight edema on eight rabbits. There was a single occurrence of moderate erythema at the day 1 observation. Desquarnation was present on five sites by day 7. There were no other dermal findings. One site had very slight erythema at study termination (day 14).

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met