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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Documentation insufficient for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1969
Report Date:
1969

Materials and methods

Principles of method if other than guideline:
Skin test for primary irritation on guinea pigs.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): tritolyl phosphite

Test animals

Species:
guinea pig
Strain:
other: Albino
Details on test animals and environmental conditions:
No data.

Test system

Type of coverage:
not specified
Preparation of test site:
shaved
Vehicle:
other: Undiluted and diluted with dimethyl phthalate (DMP)
Amount / concentration applied:
- Application volume: 0.05 ml
Duration of treatment / exposure:
No data.
Observation period:
Up to 4 weeks
Number of animals:
20
Details on study design:
See below.

Results and discussion

In vivo

Irritant / corrosive response data:
When undiluted test material was applied to the skin, initially it appeared innocuous, but after 72 h strong irritation spreading well beyond the original site of application had developed. Two weeks after the initial applications there were dryness and sloughing of the injured skin.
When the material was diluted with dimethyl phthalate it was not irritating.

Any other information on results incl. tables

Group       Conc. (%)           1 day               2 days                     3 days

1              undiluted              10 +*               2 ++*, 8 +*            10 ++++*     

2              25%                    10 neg.               10 neg.

10%                    10 neg.               10 neg.

5%                     5 +, 5 neg.           10 neg.

1%                     3 +, 7 neg.           10 neg.

neg. = negative, + = mild, ++ = moderate, +++ = strong erythema, ++++ = erythema with edema

* These reactions covered an area of 3-5 cm x 4-6 cm

Applicant's summary and conclusion

Interpretation of results:
highly irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Undiluted tritolyl phosphite produced somewhat delayed, but strong, flaring and prolonged primary irritation of guinea pig skin. Thus it is considered to be highly irritating.
Executive summary:

The test substance was subject to skin tests for primary irritation on guinea pigs. Undiluted it caused strong irritation in all ten animals, diluted with dimethyl phthalate it was not irritating. Based on these results, the test substance is considered to be highly irritating.