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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Remarks:
An OECD TG 404 was availabe to assess the skin irritation and skin corrosion
Type of information:
experimental study
Adequacy of study:
key study
Study period:
October 22, 1979 - November 5, 1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
some deviations that influence the quality of the results.
Justification for type of information:
This information is used for read across to Jessemal.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
(1981)
Deviations:
yes
Remarks:
Exposure was 24 hours and observation period restricted to 72 hours.
Principles of method if other than guideline:
J.H. Draize, "Dermal Toxicity", Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics (The Association of Food and Drug Officials of the United States, 1975), p. 47.
GLP compliance:
yes

Test material

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

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Suitable licensed dealer
- Age at study initiation: 3 months
- Weight at study initiation: approximately 2 kg
- Housing: Animals were housed in galvanized or stainless steel cages
- Diet: Free access to diet consisted of a growth and maintenance ration from a commercial producer
- Water: Free access to water.
- Acclimation period: at least 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): temperature controlled
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 mL
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
6
Details on study design:
TEST SITE:
Approximately 24 hours before treatment, animals were prepared for testing by close-clipping the skin of the mid-dorsal area of the trunk, between the scapulae and the pelvis, using a small animal clipper equipped with a #40 (surgical) head.

TREATMENT
Two sites, each 2.5 cm square, were chosen on opposite sides of the vertebral column. The test site on the left side of the animal remained intact; the test site on the right was further prepared by abrading with a sterile 22 gauge hypodermic needle. The abrasions were longitudinal epidermal incisions, sufficiently deep to penetrate the stratum corneum, but not so deep as to destroy the integrity of the derma, i.e., to cause bleeding. A single application of the test substance was made to each test site. The test substance was then covered with a 5 cm2 surgical gauze pad, and the latter held in place with adhesive tape. After both sites were treated, the entire trunk of each animal was encased in an impermeable occlusive wrapping fixed in place with adhesive tape.

REMOVAL OF TEST SUBSTANCE
Twentyfour hours after the application, the wrapping and test substance was removed and the remaining test substance was gently wiped from the skin.

OBSERVATIONS
- Irritation: The skin reactions were assessed at 24 and 72 hours after the removal of the dressings and test substance. The irritation scores and a description of all other (local) effects were recorded.

SCORING SYSTEM:
The irritation was assessed according to the Draize skin scoring table. Following the 72 hour reading, the mean scores for 24 and 72 hour gradings were averaged to determine the primary skin irritation index. A score of 5.0 or more indicates a primary dermal irritant.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
non-abraded skin
Basis:
mean
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
no data
Irritation parameter:
erythema score
Remarks:
abraded skin
Basis:
mean
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
no data
Irritation parameter:
erythema score
Remarks:
non-abraded and abraded skin
Basis:
mean
Time point:
48 h
Remarks on result:
other: 48-h findings not reported
Irritation parameter:
erythema score
Remarks:
non-abraded skin
Basis:
mean
Time point:
72 h
Score:
0.5
Max. score:
4
Reversibility:
no data
Irritation parameter:
erythema score
Remarks:
abraded skin
Basis:
mean
Time point:
72 h
Score:
0.8
Max. score:
4
Reversibility:
no data
Irritation parameter:
edema score
Remarks:
non-abraded skin
Basis:
mean
Time point:
24 h
Score:
0.2
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Remarks:
abraded skin
Basis:
mean
Time point:
24 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Remarks:
non-abraded and abraded skin
Basis:
mean
Time point:
48 h
Remarks on result:
other: 48-h findings not reported.
Irritation parameter:
edema score
Remarks:
non-abraded skin
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Remarks:
abraded skin
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
The substance caused erythema effects (very slight) 24 and 72 hours after treatment in all animals. The erythema effects were not fully reversible within 72 hours of observation. The observed edema effects were fully reversible 72 hours after treatment.
See section any other information on results incl. tables for the individual skin irritation scores.

Any other information on results incl. tables

Individual skin irritation response data (for the undiluted test substance):

        24 hours     72 hours
 Rabbit no.  Skin  Erythema  Edema  Erythema  Edema
 1 NA   1  0  1  0
   A  1  0  1  0
 2  NA  1  1  1  0
   A  1  1  1  0
 3  NA  1  0  0  0
   A  1  1  1  0
 4  NA  1  0  0  0
   A  1  0  0  0
 5  NA  1  0  0  0
   A  1  0  1  0
 6  NA  1  0  1  0
   A  1  0  1  0
 Average  NA  1  0.2  0.5  0
   A  1  0.3  0.8  0

NA: Non-abraded skin

A: Abraded skin

Combined averages: 3.8

Primary irritation index: 0.95

Applicant's summary and conclusion

Interpretation of results:
other: Not skin irritating
Remarks:
According to EU CLP (EC No. 1272/2008 and its amendments)
Conclusions:
In a skin irritation study with rabbits, performed equivalent to OECD 404 (1981) guideline and GLP principles. The exposure time was 24 hours. The erythema scores decreased from score 1 to score 0.5 within 72 hours of observation. The observed edema effects were fully reversible 72 hours after treatment. Despite the observation period not being extended to see the full reversibility of the effects, the erythema are very slight and therefore not considered for classification and labelling.
Executive summary:

The substance was tested in a skin irritation test in 6 rabbits equivalent with OECD TG 404 (1981) test guideline. The volume added to 5 cm2 was 0.5 ml and the exposure was 24 hours instead of 4hours. The skin irritation was scored at 24 and 72 hours only. In non-abraded skin, the average scores for edema and oedema decreased from 1 and 0.5, respectively at 24 hours to average 0.5 and 0, respectively at 72h indicating recovery. In view of the low scores at the 72h observation period no classification and labelling is needed&L is needed. Also because at the end of the 72 observation period 2/6 animals had no effects and 4/6 animals presented <= 1 erythema. In absence of alopecia, hyperkeratosis, hyperplasia and scaling the effects the scores are considered too minimal for C&L, despite full recovery after 14 days was not measured.

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