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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:
weight of evidence
Study period:
1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study follows protocols to similar to a recognised guideline under GLP.
Cross-reference
Reason / purpose:
read-across: supporting information

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Physical state: liquid
- Other: yellow

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Recognised supplier
- Age at study initiation: not reported
- Weight at study initiation: 2.4 - 3.0 Kg
- Housing: individually housed in grid-bottomed metal cages.
- Diet (e.g. ad libitum): certified pelleted diet ad libitum
- Water (e.g. ad libitum): mains water ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 51 - 77
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5ml test material applied to clipped backs of test animals and over areas of approximately 6sqcm
Duration of treatment / exposure:
4 hours
Observation period:
skin reaction to the test article was assessed after one, 24, 48, 72, 168 and 336 hours. Additional assessments were carried out 7 and 14 days after dosing.
Number of animals:
4 females
Details on study design:
TEST SITE
- Area of exposure: doral surface of the trunk
- % coverage: not reported. 6 sq. centimetres is described as the treatment site using a 2.5 x 2.5 cm lint pad held in place with an adhesive bandage.
- Type of wrap if used: Elastoplast elastic adhesive bandage 10cm wide.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes - test substance application site cleansed using cotton wool soaked in warm water (37°C)
- Time after start of exposure: 4 hours

SCORING SYSTEM: Consistent with Draize et al. under European Communities No. L257, 16th September 1983 was used to classify the material. (Commission Directive of 29th July 1983 adapting technical progress for the fifth time, Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances) criteria.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1 hour
Score:
1.5
Max. score:
4
Reversibility:
not fully reversible within: 14d
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 hour
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 14d
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 hour
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 14d
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 hour
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 14d
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 7 days
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 14d
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 14 days
Score:
1.25
Max. score:
4
Reversibility:
not fully reversible within: 14d
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1 hour
Score:
0.75
Max. score:
4
Reversibility:
not fully reversible within: 14d
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 hour
Score:
1.75
Max. score:
4
Reversibility:
not fully reversible within: 14d
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48 hour
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 14d
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 hour
Score:
2.25
Max. score:
4
Reversibility:
not fully reversible within: 14d
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 7 days
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 14d
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 14 days
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 14d
Irritant / corrosive response data:
Individual scores are presented in the full study report and presented in table 1.

Any other information on results incl. tables

Table 1. individual scores

 

Time

Erythema

Oedema

Comments

 

 

 

 

 

1

1 hour

2

1

 

2

 

2

0

 

3

 

1

1

 

4

 

1

1

 

1

24 hours

2

2

 

2

 

2

1

 

3

 

2

2

 

4

 

2

2

 

1

48 hours

2

2

 

2

 

2

2

 

3

 

2

2

 

4

 

2

2

 

1

72 hours

2

3

 

2

 

2

2

 

3

 

2

2

 

4

 

2

2

Treated skin thickened

1

7 days

2

3

Treated skin thickened

2

 

2

3

Treated skin thickened

3

 

2

3

Treated skin thickened

4

 

2

3

Treated skin thickened

1

14 days

1

0

Slight desquamation

2

 

2

2

Desquamation

3

 

1

1

Slight desquamation

4

 

1

1

Slight desquamation

 

 

 

 

 

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the study the test substance is considered to be irritating to skin.
Executive summary:

The study was performed in a method equivalent or similar to EU Method B.4 under GLP to assess the irritancy potential of the test substance to the skin of the New Zealand White rabbit. The test substance was applied over an area of approximately 2.5cm square to the clipped backs of 4 albino rabbits. The test substance was held in contact with the skin under a semi-occlusive patch for a 4 hour period. After this time the patches were removed and the skin reaction to the test substance was assessed after one, 24, 48 and 72 hours. Additional assessments were carried out 7 and 14 days after dosing to determine the degree of reversibility of the skin reaction. The response increased within twenty four hours of dosing when well defined erythema of the skin was noted in all four animals. Slight oedema was apparent and very slight oedema of the skin was observed. Well defined erythema and slight oedema were observed at the treated sites at the forty eight hour observation. Seventy two hours after dosing slight increase in oedematous reaction had occurred in one animal and thickening of the treated skin was observed in a second animal. Well defined erythema, moderate oedema and thickening of the treated skin was observed in all organisms seven days after dosing. This reaction declined and fourteen days after dosing well defined erythema and slight oedema remained in one organism, and very slight irritation was observed at the treated sites of the remaining organisms. Desquamation from the skin surface was noted in all four rabbits of the group. Applicant recalculation of the results indicates that under the conditions of this study, that the mean erythema scores between 24 and 72 hours were > 2.0 in at least 3 of 4 organisms and the response had not fully reversed within a 14 day period. The test item should be considered as irritating to the skin.