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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:
comparable to guideline study with acceptable restrictions
Justification for type of information:
Please See Category Approach
Cross-reference
Reason / purpose:
read-across source
Reference
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:
comparable to guideline study with acceptable restrictions
Qualifier:
according to
Guideline:
other: As described in the U.S. Federal Register Vol. 38, No. 187, Section 1500:41, 1973
Deviations:
not specified
Principles of method if other than guideline:
Shaved skin; abraded and non-abraded; two sites per animal; exposed area covered; oedema and erythema assessed at 24 and 72 hours; primary irritation index evaluated following Draize scoring procedure.
GLP compliance:
no
Justification for test system used:
Method was valid before REACH and is accepted.
Vehicle:
unchanged (no vehicle)
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS- Source: "recognized breeders"- Age at study initiation: 14-16 weeks- Weight at study initiation: 2.3 Kg average- Housing: caged singularly- Diet (e.g. ad libitum): ad libitum- Water (e.g. ad libitum): ad libitum- Acclimation period:ENVIRONMENTAL CONDITIONS- Temperature (°C): 17 °C +/- 2 °C- Humidity (%): 50-70%- Air changes (per hr): no data- Photoperiod (hrs dark / hrs light): natural lighting conditionsIN-LIFE DATES: From: To: no data
Type of coverage:
occlusive
Preparation of test site:
abraded
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL- Amount(s) applied (volume or weight with unit): 0.5 mL- Concentration (if solution): undilutedVEHICLE- Amount(s) applied (volume or weight with unit): no vehicle
Duration of treatment / exposure:
single application; patch removed at 24 hours but no indication of excess material wiped off
Observation period:
24 and 72 hours
Number of animals:
6 females
Details on study design:
TEST SITE- Area of exposure: Two 2.5 cm sites, one abraded and one not abraded- % coverage: no data- Type of wrap if used: Smith & Nephew Elastic bandage covered entire trunk of animal- 24 hours prior to dermal application, the backs of the rabbits were shaved over an area of at least 10% of the trunk. Two test sites lateral to the mid line of the back were used on each animal. Immediately before teh application of the test substance, the right hand site was abraded witht he point of a sterile hypodermic needle. The abrasions were sufficiently deep to penetrate the stratum corneum but not to damage the dermis. The left hand site remained intact. REMOVAL OF TEST SUBSTANCE- Washing (if done): not indicatedSCORING SYSTEM: J.H. Draize (1959) - primary irritation score (average for erythema and oedema for all six animals)
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
>= 0.1
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
No irritation on intact skin. Slight erythema (score = 1) in 3 of 6 animals at 24 hours with abraded skin. No oedema observed in any animals.
Other effects:
None reported.
Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: primary irritation score of 0.1
Conclusions:
Sodium toluene sulfonate is a mild irritant

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: As described in the U.S. Federal Register Vol. 38, No. 187, Section 1500:41, 1973
Deviations:
not specified
Principles of method if other than guideline:
Shaved skin; abraded and non-abraded; two sites per animal; exposed area covered; oedema and erythema assessed at 24 and 72 hours; primary irritation index evaluated following Draize scoring procedure.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid: bulk
Details on test material:
- Name of test material : K-Cumenesulfonate (dried material)
- Substance type: Product
- Physical state: solid
- Analytical purity:
- Impurities (identity and concentrations):
- Purity test date:
- Lot/batch No.: T7714
- Expiration date of the lot/batch:

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS- Source: "recognized breeders"- Age at study initiation: 14-16 weeks- Weight at study initiation: 2.3 Kg average- Housing: caged singularly- Diet (e.g. ad libitum): ad libitum- Water (e.g. ad libitum): ad libitum- Acclimation period:ENVIRONMENTAL CONDITIONS- Temperature (°C): 17 °C +/- 2 °C- Humidity (%): 50-70%- Air changes (per hr): no data- Photoperiod (hrs dark / hrs light): natural lighting conditionsIN-LIFE DATES: From: To: no data

Test system

Type of coverage:
occlusive
Preparation of test site:
abraded
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL- Amount(s) applied (volume or weight with unit): 0.5 mL- Concentration (if solution): undilutedVEHICLE- Amount(s) applied (volume or weight with unit): no vehicle
Duration of treatment / exposure:
single application; patch removed at 24 hours but no indication of excess material wiped off
Observation period:
24 and 72 hours
Number of animals:
6 females
Details on study design:
TEST SITE- Area of exposure: Two 2.5 cm sites, one abraded and one not abraded- % coverage: no data- Type of wrap if used: Smith & Nephew Elastic bandage covered entire trunk of animal- 24 hours prior to dermal application, the backs of the rabbits were shaved over an area of at least 10% of the trunk. Two test sites lateral to the mid line of the back were used on each animal. Immediately before teh application of the test substance, the right hand site was abraded witht he point of a sterile hypodermic needle. The abrasions were sufficiently deep to penetrate the stratum corneum but not to damage the dermis. The left hand site remained intact. REMOVAL OF TEST SUBSTANCE- Washing (if done): not indicatedSCORING SYSTEM: J.H. Draize (1959) - primary irritation score (average for erythema and oedema for all six animals)

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
>= 0.1
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
No irritation on intact skin. Slight erythema (score = 1) in 3 of 6 animals at 24 hours with abraded skin. No oedema observed in any animals.
Other effects:
None reported.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: primary irritation score of 0.1
Conclusions:
Sodium toluene sulfonate is a mild irritant