Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
27.7.1982-30.7.1982
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the appropriate OECD guideline and in compliance with GLP.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Nottingham University, School of Agriculture, Sutton Bonington, Leicestershire
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.21-3.09kg
- Housing: individually housed in suspended metal cages
- Diet: standard laboratory diet, ad libitum
- Water: ad libitum
- Acclimation period: minimum of 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Air changes (per hr): ca. 15
- Humidity (%): not controlled but remained within a range of 76-80 %RH
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): undiluted

Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48, 72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: dorsal/flank area
- Type of wrap if used: test material was held in contact with skin with an occlusive patch, and the trunk of the animal wrapped in an elasticated corset


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Any resdual material was immediately removed by gentle swabbing with cotton wool soaked in lukewarm water. if the material was found to be insoluble in water, ether or acetone could be used.
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize 1959

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24/48/72h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24/48/72h
Score:
0
Max. score:
4
Irritant / corrosive response data:
Reported primary irritation index (Group total / 12) was 0.1. The test material produced minimal cutaneous irritation in 1/3 rabbits. there was no evidence of corrosion in any animal. Very slight erythema was observed in one rabbit at the one hour reading only. Two rabbits did not show any observable response to treatment throughout the 72 hours observation period.

Any other information on results incl. tables

The active acid content of the test material is 25%.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
A test report, conducted according to the appropriate OECD test guideline and in compliance with GLP reports the test substance to be a mild irritant. However, according to the current EU regulation (EC 1272/2008) the substance is considered not irritating.