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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
Study period:
1972
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets scientific standards with acceptable restrictions (partly limited documentation, e.g. individual data not stated).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1972

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Classification of corrosive hazards, Federal Register, Vol 37, No 57, § 173.240
Deviations:
not applicable
Principles of method if other than guideline:
0.5 mL of undiluted sample was applied to the clipped, intact skin of 3 NZW male and female rabbits under a one inch by one inch square patch, two single layers thick. The patches were held in place with adhesive tape in such a manner that evaporation was retarded, but not prevented, for the 4 h exposure period.
Scoring according to Draize et al. (1944) J Pharm Exp Therap 82
GLP compliance:
no
Remarks:
Study from 1972 (GLP was not compulsory at the time the study was performed).

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Lot/batch No.: T 613
crude test substance (no further data)

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.5 mL of undiluted sample
Duration of treatment / exposure:
4 hrs
Observation period:
168 hrs
Number of animals:
3 male and female NZW rabbits

Results and discussion

Any other information on results incl. tables

Time Point

Effects

1 h

no skin changes; zero readings

4 hrs

very slight erythema, very slight to slight oedema

24 hrs

slight erythema and oedema

48 hrs

slight erythema and oedema

72 hrs

slight erythema, very slight to slight oedema

120 hrs

no erythema or oedema; zero readings

168 hrs

no erythema or oedema; zero readings

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information
Conclusions:
The substance was classed as not corrosive.
Executive summary:

In this older study 0.5 mL of undiluted sample was applied to the clipped, intact skin of 3 NZW male and female rabbits under semi-occlusive conditions over a 4 h exposure period. Scoring was according to Draize et al. (1944).

The substance was classed as not corrosive.