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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific and national standards, acceptable for assessment

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:
occlusive dressing, 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; the animals with abraded skin were not taken into account for assessment of skin irritation.

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


TEST MATERIAL
- Amount applied: no data
- For solids, paste formed: yes, aqueous


VEHICLE
- Amount applied: an undefined amount of water was added to the solid test material to form an aqueous paste

Duration of exposure:
24 h
Doses:
2000, 3000, 4000, and 5000 mg/kg bw as aqueous paste
No. of animals per sex per dose:
4 animals per dose; sex not specified
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 levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
none: 0/16 (0/4 in each dose group)
Clinical signs:
All animals of all dose group appeared normal during the observation period.
Body weight:
normal
Gross pathology:
No gross pathological findings were noted.
Other findings:
Dermal reactions were limited to slight erythema and edema which were fully reversible at the latest within 4 days.

Applicant's summary and conclusion