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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
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:
other: OECD Guideline 402 (Acute Dermal Toxicity), including skin reactions
GLP compliance:
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

Test system

Type of coverage:
occlusive
Preparation of test site:
other: abraded and intact (shaved)
Vehicle:
water
Amount / concentration applied:
Concentrations: 2000, 3000, 4000, and 5000 mg/kg bw
Duration of treatment / exposure:
24 h
Observation period:
Scoring on days 1 through 14 after test initiation
Number of animals:
16 (4 x 4)
Details on study design:
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


SCORING SYSTEM: Draize system

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 + 48 + 72 h
Score:
< 1
Max. score:
8
Irritant / corrosive response data:
Dermal reactions limited to slight erythema and edema (score range 0 - 2).

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Classification: not irritating (EU and GHS)