Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Remarks:
comparable to guideline study with acceptable restrictions No CoA, pre-GLP, limited information on animals and conditions, only 2 animals used per each dose level, occlusive dressing, no necropsy, no data on individual animals.
Adequacy of study:
supporting study
Study period:
1970
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
significant methodological deficiencies

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1970
Report date:
1970

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
no
Remarks:
performed pre-GLP
Test type:
standard acute method
Limit test:
no

Test material

Test material form:
liquid
Details on test material:
clear liquid
Specific details on test material used for the study:
The test materials were received from the Lucidol Division, Pennwalt Corporation, Buffalo, New York, on June 12, 1970. It was received as a clear liquid packed in dry ice.

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
Source: no data
- Age at study initiation: no data
- Weight at study initiation: 1810 - 2450 grams
- Housing: individually in hanging metal cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data

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

IN-LIFE DATES: From: To: no data

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: back
- % coverage: no data
- Type of wrap if used: occluded and wrapped with a gauze bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): tepid tap water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 200 and 2000 mg/kg
Duration of exposure:
24 hours
Doses:
200 and 2000 mg/kg
No. of animals per sex per dose:
2
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Body weights were measured initially and at 7 and 14 days after compound application.
- Necropsy of survivors performed: no
Statistics:
none

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
All of the rabbits at each of the dosage levels tested survived the study period.
Clinical signs:
Twenty-four hours after application, erythema (very slight to moderate) and edema (slight to moderate) was observed at the site of application in each animal tested. Desquamation was noted during the 14 day observation period. Slight erythema remained in evidence on the 14th day following application of the test material.
Body weight:
All animals exhibited normal gains in body weight during the period of study.
Gross pathology:
Not applicable

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
None of the animals died at 2000 mg/kg bw, there were only 2 animals in each group. The study is not suitable for C&L purposes.
Executive summary:

None of the animals died at 2000 mg/kg bw, there were only 2 animals in each group. The study is not suitable for C&L purposes.