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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
Study period:
From Jun. 1978 to Mar. 6, 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
- more stringent protocol with 24h occlusive application, data for single animals not given
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
other: Chbb: HM -SPF
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: animals purchased
- Age at study initiation: Not reported
- Weight at study initiation: 2.14 to 2.75 kg (mean weight of 2.35 kg)
- Fasting period before study: Not reported
- Housing: standard cages (manufactured by Becker) on metal floor grids.
- Diet (e.g. ad libitum): Brand-Purina mixed feed manufactured by Kraftfutterwerke GmbH, Wisebaden-Schierstein branch ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: Not reported

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 27 ± 7
- Humidity (%): 52 ± 20
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): Not reported

Test system

Type of coverage:
occlusive
Preparation of test site:
other: abraded / intact
Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

CONTROL:
0.5 mL of water was appliaed in a similar fashion to the right half of the animals' backs
Duration of treatment / exposure:
24 hours
Observation period:
7 days
Number of animals:
4 females tested with intact skin and 4 females tested with scarified skin
Details on study design:
TEST SITE
- Area of exposure: back
- % coverage: 4 cm2

REMOVAL OF TEST SUBSTANCE
- Washing (if done): After patches were removed, any remaining substance was washed off with water.
- Time after start of exposure:24 hours

SCORING SYSTEM: Local changes were assessed according to the DRAIZE (1959).

Degree of irritation:
0 = without irritation
1 = questionable
2 = slight
3 = pronounced
4 = severe

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
mean
Time point:
24 h
Score:
0.25
Max. score:
1
Reversibility:
fully reversible within: 3 days
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
mean
Time point:
48 h
Score:
0.25
Max. score:
1
Reversibility:
fully reversible within: 3 days
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
mean
Time point:
7 d
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Remarks:
scarified skin
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Remarks:
scarified skin
Basis:
mean
Time point:
48 h
Score:
0.25
Max. score:
1
Reversibility:
fully reversible within: 3 days
Irritation parameter:
erythema score
Remarks:
scarified skin
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
7 d
Score:
0
Max. score:
0
Irritant / corrosive response data:
The single application of 0.5 ml of the test item to the shorn skin on the backs of each of the rabbits did not show signs of irritation after the 24-hour exposure period.
Other effects:
All of the rabbits were clinically normal. The body weight did not differ from that of rabbits of the same age that were not treated. All of the animals survived the 7-day observation period.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item was found to be not irritant to the skin.
Executive summary:

In this (OECD 404) study conducted to generally accepted scientific standards, the test material (EC 231 -272 -0) was induced mean erythema scores of 0.25 in 1 of the 4 test animals (rabbit, intact skin) across the 24 and 48 hour observation periods. In addition a mean erythema score of 0.25 was observed for one test animal with scarified skin at the 48 hour observation period. All applications occured under occlusive conditions and were fully reversible within 3 days. The result of the test is not sufficient to meet the criteria for classification as a skin irritant under the criteria of the EU Classification, Labelling, and Packaging (CLP) regulation (1272/2008).