Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 1980-02-28 to 1980-05-28
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP study similar to OECD TG 402

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
1. fur was clipped immediately prior to dosing and not 24 hours before the test as stated in the guideline. 2. Abrasions were made in even numbered rabbits, whereas according to guideline, care must be taken to avoid abrading the skin. 3. males & females
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: Nicholas Helf
- Age at study initiation: approximately 8 weeks old
- Weight at study initiation: 2.2-2.8 kg
- Fasting period before study: no
- Housing: 2/cage in suspended wire mesh cages
- Diet (e.g. ad libitum): Fresh Purine rabbit chow, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

IN-LIFE DATES: From: 1980-02-28 To: 1980-03-19

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 200 cm^2
- % coverage: 10
- Type of wrap if used: impervious material

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no, only wiped
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5.0 g/kg
- Concentration (if solution): undiluted
Duration of exposure:
24 h
Doses:
5.0 g/kg bw
No. of animals per sex per dose:
2 males and 8 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations daily and weighing on day 0 and day 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, mortality
Statistics:
not reported

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No animal died during the observation period of 14 days.
Clinical signs:
Isolated instances of diarrhea and mucus in stall were noted during the study. Nine animals were normal on day 14.
Gross pathology:
One animal, sacrificed on day 14 was normal. Nine animals, sacrificed on day 14, had scaly treated skin.
Other findings:
Skin reactions were variable ranging from slight erythema and edema to severe erythema and moderate edema.

Applicant's summary and conclusion

Interpretation of results:
other: EU CLP criteria
Conclusions:
The substance was acutely non toxic to rabbits in an acute dermal toxicity test with an LD50 value of >5000 mg/kg bw. The substance is not classified according to CLP.
Executive summary:

Ten (2 male and 8 female) healthy New Zealand White rabbits with initial body weights of 2.2 -2.8 kilograms received one dermal application 5000 mg/kg bw test item. The test material was applied to clipped, intact or abraded abdominal skin under occluded patches for 24 hours. Afterwards the exposure site was wiped, but not washed, to remove excess material. Observations for mortality and/or systemic effects were made daily for 14 days. Dermal reactions were scored at 24 hours by the Draize scoring system and were variable ranging from slight erythema and edema to severe erythema and moderate edema. Body weights were recorded pretest and at 14 days. All animals survived until end of the study and gross necropsy was conducted. In 9/10 animals scaly treated skin was observed. The acute dermal LD50 >5 g/kg.