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Description of key information

Skin and eye irritation are discussed.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1975; date not specified.
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP study, no specific methodology followed although documented report available.
Reason / purpose for cross-reference:
reference to same study
Qualifier:
according to guideline
Guideline:
other: Standard Federal Hazardous Substances Labeling Act tests
Deviations:
no
Principles of method if other than guideline:
The acute skin irritation test was conducted on 6 adult albino rabbits selected from healthy, acclimated animals. The method employed is patterned after the Draize procedure as described in 16 CFR 1500.41 . The back of each animal was shaved free of hair; intact skin was exposed on the left half of the shaved area, and the abraded on the right half. The material (0.5 ml or 0.5 g) was introduced under a square patch of surgical gauze measuring 1 inch x 1 inch. Patches were removed after 24 hours and observations recorded. Observations were again made after 72 hours.
GLP compliance:
no
Species:
rabbit
Strain:
other: albino
Details on test animals or test system and environmental conditions:
None provided.
Type of coverage:
occlusive
Preparation of test site:
other: shaved and part of test site abraded
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
0.5 ml or 0.5 g
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
6
Details on study design:
The acute skin irritation test was conducted on 6 adult albino rabbits selected from healthy, acclimated animals. The method employed is patterned after the Draize procedure as described in 16 CFR 1500.41 . The back of each animal was shaved free of hair; intact skin was exposed on the left half of the shaved area, and the abraded on the right half. The material (0.5 ml or 0.5 g) was introduced under a square patch of surgical gauze measuring 1 inch x 1 inch. Patches were removed after 24 hours and observations recorded. Observations were again made after 72 hours.
Irritation parameter:
overall irritation score
Basis:
mean
Score:
0.04
Remarks on result:
other: Draize Scoring Criteria: Non irritants are expected to produce an average score of 0.5 or less
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
On the basis of the data, the test material is not an irritant to the rabbit skin. This material is not considered a corrosive substance.
Executive summary:

Kronitex TCP was tested for acute skin irritation and was found not to be an irritant to rabbit skin. This material is not considered a corrosive substance.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation / Corrosion.

Two studies were evaluated on this endpoint. In these,Kronitex TCP was tested for primary dermal irritation and corrosiveness. Results indicate that has a potential for slight dermal irritation, although effects were reversible within 24 hours. It is not a dermal corrosive. No risk phrase or classification is required.

Eye irritation.

 Two studies were evaluated on this endpoint as follows:

Kronitex TCP was tested for acute irritation and was found not to be an irritant to the rabbit eye when not followed by a washout or followed by a washout 4 seconds after instillation of the test material. Effects were noted in one study; however these were fully reversible within 72 hours. No classification is applicable.

Respiratory irritation was not assessed; however no effects on the animals were noted in any associated studies.

Justification for selection of skin irritation / corrosion endpoint:

K2

Justification for selection of eye irritation endpoint:

K2

Justification for classification or non-classification

The above studies have all been ranked reliability 2 according to the Klimish et al system. This ranking was deemed appropriate because the studies were not conducted to GLP or in compliance with agreed protocols. Some of the reports do not detail a specific method; however it documents dose levels and responses in detail, so is deemed appropriate for use in the support of a formal registration. Sufficient dose ranges and numbers are detailed; hence it is appropriate for use based on reliability and animal welfare grounds.

Justification for classification or non classification

The above results triggered no classification under the CLP Regulation (EC No 1272/2008).

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