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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
Remarks:
details about test substance, animal source/breeder, in life dates and animal enviroment (air changes per hour) are missing

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
other: "Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act
Version / remarks:
Sect. 191.11 (February 1965)
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
12 May 1981 / The study was performed before the guideline was published.
Deviations:
yes
Remarks:
exposure duration (24h instead of 6h), no washing step, no readings after 30-60 minutes and 48 hours, different scoring
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: /
- Age at study initiation: 17-20 weeks
- Weight at study initiation: 3.09 kg male and 3.10 kg female
- Housing: singly
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum, sterile
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1
- Humidity (%): 50-70
- Air changes (per hr): /
- Photoperiod (hrs dark / hrs light): 10h, 8-18.00 hours

Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved and right hand site abraded
Vehicle:
other: PEG 50 % aqueous solution
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1 ml containing 0.5 g
- Concentration (if solution): 50 %

VEHICLE
- Amount(s) applied (volume or weight with unit): 1 ml
- Concentration (if solution): 50 %

10 g of the test compound mixed with 12 ml of a 50 % aqueous solution of polyethylene glycol to make a suspension of 20ml, 10 ml of which was applied to each test site on a 2.5 cm square gauze pad.
Duration of treatment / exposure:
24h
Observation period:
72h
Number of animals:
5 male, 1 female
Details on study design:
TEST SITE
- Area of exposure: back/flanks
- % coverage: 10
- Type of wrap if used: aluminium foil secured with "Sleek" adhesive tape

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72h
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24h
Score:
1.17
Max. score:
4
Reversibility:
fully reversible within: 72h
Remarks on result:
other: abraded skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24h
Score:
1.17
Max. score:
4
Reversibility:
fully reversible within: 72h
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 72h
Remarks on result:
other: abraded skin
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: all time points
Score:
1.2
Max. score:
8
Remarks on result:
other: slightly irritating according Draize system
Irritant / corrosive response data:
24 hours.
Slight to well defined erythema was seen on all sites and very slight to slight oedema on 5/6 intact and 4/6 abraded.sites.
72 hours.
All sites were normal.

Any other information on results incl. tables

Generally, there was very little difference seen in the reactions between intact and abraded sites.

The primary irritation score was 1.2.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the results of the test and the primary irritation score of 1.2, no indication for classification according to GHS is indicated.
Executive summary:

In the primary skin irritation test, similar to OECD 404, male and female New Zealand White rabbits were dermally treated with the test substance.

Five male and one female were singly housed and shaved (and partially abraded) before the substance was applied as a aqueous solution with polyethylene glycol as vehicle.

The test substance was covered by an occlusive coverage and the test site was treated for 24 hours.

After the removal of the coverage, the site was observed for further 72 hours.

There was very little difference seen in the reactions between intact and abraded sites and the primary irritation score was 1.2.

The test substance is not considered to be skin irritant to rabbits.