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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

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: see 'Remark'
Remarks:
The study was not conducted under GLP. The study was conducted outside of current guidelines (dose volume, lack of occlusion, observation time points).This study was selected as the key study because the information provided for the hazard endpoint is sufficient for the purpose of classification and labeling and/or risk assessment.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Principles of method if other than guideline:
For the primary irritation test, 0.05 mL of a 30% and a 3% solution in distilled water was applied to the shaved, intact shoulder skin of 10 male albino guinea pigs. A range-finding study was conducted with 3 male albino guinea pigs to test for skin irritation potential. Observations were made at 24- and 48-hours after treatment.
GLP compliance:
not specified

Test material

Constituent 1
Details on test material:
- Purity: Fisher Scientific Co. Certified Grade


Test animals

Species:
guinea pig
Strain:
not specified
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: Not reported
- Weight at study initiation: Not reported
- Housing: Not reported
- Diet (e.g. ad libitum): Not reported
- Water (e.g. ad libitum): Not reported
- Acclimation period: Not reported

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not reported
- Humidity (%): Not reported
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): Not reported

Test system

Type of coverage:
open
Preparation of test site:
shaved
Vehicle:
other: Distilled water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.05 mL
- Concentration (if solution): 30 or 3%
Duration of treatment / exposure:
48 hours
Observation period:
Observations were made at 24- and 48-hours after treatment.
Number of animals:
10 guinea pigs
Details on study design:
SCORING SYSTEM: + = mild erythema; ++ = moderate erythema; +++ = strong erythema; ++++ = erythema plus edema; +++++ = necrosis

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
other: all animals 30% exposure
Time point:
other: 24 hours
Score:
0
Irritation parameter:
overall irritation score
Basis:
other: all animals 30% exposure
Time point:
other: 48 hours
Score:
0
Irritation parameter:
overall irritation score
Basis:
other: all animals 3% exposure
Time point:
other: 24 hours
Score:
0
Irritation parameter:
overall irritation score
Basis:
other: all animals 3% exposure
Time point:
other: 48 hours
Score:
0
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: not determined
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: not determined
Irritant / corrosive response data:
No animals showed any signs of irritation.

Any other information on results incl. tables

No irritation was observed in the range-finding test. No irritation was observed in the primary irritation test as a 30% or a 3% solution at 24 and 48 hours.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
This study and the conclusions which are drawn from it fulfill the quality criteria (validity, reliability, repeatability). The test substance as either a 30% or 3% solution in distilled water caused no irritation at 24 and 48 hours on the shaved, intact skin of guinea pigs.
Executive summary:

A 0.05 mL aliquot of a 30% and a 3% solution of the test substance in distilled water was applied to the shaved, intact shoulder skin of 10 male albino guinea pigs. Observations were made at 24- and 48-hours after treatment. The test substance as either a 30% or 3% solution in distilled water caused no irritation at 24 and 48 hours on the shaved, intact skin of guinea pigs.