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: Meets generally accepted scientific asnd national standards, limited documentation, acceptable for assessment
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
24-exposure, abraded and intact skin
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
ZEOLEX 23A - surface area (BET): 65 -80 m2/g, pH 9.8 - 10.6

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
not specified

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
The TS was applied as paste to the intact and abraded skin of 2 animals of each dose group
TEST SITE
- Area of exposure: no data
- % coverage: no data
- Type of wrap if used: impervious bandage
- The TS was applied as paste to the intact and abraded skin of 2 animals each of the dose groups

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): no data
- For solids, paste formed: yes, aqueous


VEHICLE
- Amount(s) applied (volume or weight with unit): no data

Duration of exposure:
24 h
Doses:
2000, 3000, 4000, and 5000 mg/kg as aqueous paste
No. of animals per sex per dose:
4
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights

Results and discussion

Effect levelsopen allclose all
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Dose descriptor:
LD0
Effect level:
>= 5 000 mg/kg bw
Mortality:
none: 0/16 (0/4 per each dose group)
Clinical signs:
no data
Body weight:
normal
Gross pathology:
No pathological findings
Other findings:
Dermal reactions were limited to slight erythema and edema.

Applicant's summary and conclusion