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Diss Factsheets

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:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: 79/831/C.E.E, Annex V Section B.4
Deviations:
no
GLP compliance:
no

Test material

Constituent 1
Test material form:
other: Amber Liquid
Details on test material:
- Name of test material (as cited in study report): Kathon™ 886
- Physical state: Amber liquid
- Stability under test conditions: stable at room temperature
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Rohm and Haas, Batch No. not described

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
- Stability under test conditions: Stable at room temperature
- Solubility and stability of the test substance in the solvent/vehicle: Not applicable
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: Not applicable

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: No
- Final dilution of a dissolved solid, stock liquid or gel: Undiluted

OTHER SPECIFICS: Purity of test material was 13.9%

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Elevage Scientifique des Dombes (Romans, 01400 Chatillon Sur Chalaronne, France)
- Age at study initiation: Adult
- Weight at study initiation: 2340 to 2500 g

Test system

Type of coverage:
semiocclusive
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
Duration of treatment / exposure:
3 rabbits for 1 h and 3 rabbits for 4 h
Observation period:
60 min after removal of gauze and then once daily for 12 days
Number of animals:
6 per dose
Details on study design:
TEST SITE
- Area of exposure: right flank
- Type of wrap if used: The test article was covered with a gauze patch, held in place with non-irritating tape. The patch was closely held in contact with the skin by means of a suitable semi occlusive dressing for the duration of the exposure period. During this time, the animals were kept in restraining boxes.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Slightly washed with sterile water
- Time after start of exposure: 3 rabbits for 1 h and 3 rabbits for 4 h

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 hours
Score:
2.3
Reversibility:
fully reversible within: 11 days after dosing
Remarks on result:
other: 1 h exposure
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 hours
Score:
2
Reversibility:
fully reversible within: 11 days after dosing
Remarks on result:
other: 1 hour expsoure
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 hours
Score:
0.7
Reversibility:
fully reversible within: 11 days after dosing
Remarks on result:
other: 1 hour expsoure
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 hours
Score:
3
Reversibility:
fully reversible within: 11 days after dosing
Remarks on result:
other: 4 hour expsoure
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 hours
Score:
2.7
Reversibility:
fully reversible within: 11 days after dosing
Remarks on result:
other: 4 hour expsoure
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 hours
Score:
1.7
Reversibility:
fully reversible within: 11 days after dosing
Remarks on result:
other: 4 hour expsoure
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 hours
Score:
2.3
Reversibility:
fully reversible within: Total recovery from edema was recorded after 8 days observation period
Remarks on result:
other: 1 hour expsoure
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48 hours
Score:
1.3
Reversibility:
fully reversible within: Total recovery from edema was recorded after 8 days observation period
Remarks on result:
other: 1 hour expsoure
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 hours
Score:
0.3
Reversibility:
fully reversible within: Total recovery from edema was recorded after 8 days observation period
Remarks on result:
other: 1 hour expsoure
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 hours
Score:
3.7
Reversibility:
fully reversible within: Total recovery from edema was recorded after 8 days observation period
Remarks on result:
other: 4 hour expsoure
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48 hours
Score:
2
Reversibility:
fully reversible within: Total recovery from edema was recorded after 8 days observation period
Remarks on result:
other: 4 hour expsoure
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 hours
Score:
0.7
Reversibility:
fully reversible within: Total recovery from edema was recorded after 8 days observation period
Remarks on result:
other: 4 hour expsoure
Irritant / corrosive response data:
The final scoring of irritancy has been calculated with the records after one hour, 24 hours and 48 hours. The value, obtained after calculation is 5.55.
Effects were reversible. At 3 days, only three animals had a slight edema. Total recovery from edema was recorded after 8 days observation period. As for erythema, a reversal was observed after 72 hours, with a total recovery after 11 days after dosing.
Other effects:
- Other adverse systemic effects: A small change in the body weight gain was observed on day 8 of study for the 3 animals treated for 4 hours and no incidence was recorded for the animals treated for one hour. Body weight gain was normal by day 12. No clinical signs affecting the behaviour of the animals were recorded during the conduct of the study.

Any other information on results incl. tables

Table for skin irritation study – 1 h exposure

score (average animals investigated)

time

Erythema

Edema

average score
Draize scores
(0 to maximum 4)

60 min

2.7

4.0

24 h

2.3

2.3

48 h

2.0

1.3

72 h

0.7

0.3

other times

96 h  (4 days)

0.7

0.3

120 h (5 days)

0.7

0.3

144 h (6 days)

0.7

0.3

168 h (7 days)

1.0

0.3

192 h (8 days)

1.0

0.3

216 h (9 days)

0.3

0.0

240 h (10 days)

0.3

0.0

264 h (11 days)

0.0

0.0

reversibility: *

c

c

average time for reversibility

after 240 h

after 192 h

*c : completely reversible; n c : not completely reversible; n : not reversible.

Table for skin irritation study – 4 h exposure

score (average animals investigated)

time

Erythema

Edema

average score
Draize scores
(0 to maximum 4)

60 min

3.7

3.7

24 h

3.0

3.7

48 h

2.7

2.0

72 h

1.7

0.7

other times

96 h  (4 days)

1.7

0.7

120 h (5 days)

2.0

0.7

144 h (6 days)

2.0

0.7

168 h (7 days)

2.0

0.7

192 h (8 days)

1.7

0.0

216 h (9 days)

1.7

0.0

240 h (10 days)

0.7

0.0

264 h (11 days)

0.3

0.0

reversibility: *

c

c

average time for reversibility

after 264 h

after 168 h

*c : completely reversible; n c : not completely reversible; n : not reversible

Applicant's summary and conclusion

Interpretation of results:
Category 1B (corrosive) based on GHS criteria
Conclusions:
A severe edema (score = 4) was observed in five animals and one animal had a moderate edema (score = 3) one hour after patch removal. This edema was raised more than 2 mm and extended beyond the area of exposure. By day 3, this irritation reversed such that only 3 animals had a slight edema. There was total recovery after 8 days.
One animal had a well-defined erythema with slight eschar formations. A reversal was observed after 72 h with total recovery after 11 days.
Executive summary:

The study was conducted in accordance with OECD Guideline 404, Acute dermal irritation/corrosion. There were no guideline deviations.

A severe edema (score = 4) was observed in five animals and one animal had a moderate edema (score = 3) one hour after patch removal. This edema was raised more than 2 mm and extended beyond the area of exposure. By day 3, this irritation reversed such that only 3 animals had a slight edema. There was total recovery after 8 days. One animal had a well-defined erythema with slight eschar formations. A reversal was observed after 72 h with total recovery after 11 days.