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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:
15 August 2005 to 24 October 2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report Date:
2005

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
other: Japanese White
Details on test animals and environmental conditions:
TEST ANIMALS- Source: Japan Laboratory Animals Inc.- Age at study initiation: 18 weeks (16 weeks upon receipt)- Weight at study initiation: 2.97-3.13 kg- Housing: individually in aluminium cages (W 360 x D 550 x H 350 mm; Nippon Cage Co., Ltd.) with wire mesh bottoms- Diet: RC4 pelleted diet (Oriental Yeast Co., Ltd., Lot Nos. 050620 and 050727) provided in stainless steel feeders, ad libitum- Water: tap water (Fulimi Water Union), provided via automatic water supply system, ad libitum- Acclimation period: 12 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 23±5- Humidity (%): 55±25- Air changes (per hr): 11-14- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: not required, untreated sites of the same animals served as control
Amount / concentration applied:
TEST MATERIAL- Amount(s) applied: 0.5 mL
Duration of treatment / exposure:
3 min, 1 h, and 4 h
Observation period:
14 days
Number of animals:
3
Details on study design:
TEST SITE- Area of exposure: 2.5 x 2.5 cm²- Type of wrap if used: lint sheet covered and fixed with Kinesio tex tape (Kinesio Co., LTD.)REMOVAL OF TEST SUBSTANCE- Washing (if done): with absorbant cotton soaked with water for injection- Time after start of exposure: 3 min, 1 h, and 4 hSCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean over 24, 48, and 72 h
Score:
2.7
Max. score:
4
Reversibility:
fully reversible within: 9 days
Remarks on result:
other: 4 h exposure duration; scaling on days 5-9
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean over 24, 48, and 72 h
Score:
3.7
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: 4 h exposure duration; eschar from 72 h post exposure until study termination
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean over 24, 48, and 72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: 4 h exposure duration; scaling from day 6 until study termination
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: mean over 24, 48, and 72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: 4 h exposure duration
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: mean over 24, 48, and 72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 13 days
Remarks on result:
other: 4 h exposure duration
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: mean over 24, 48, and 72 h
Score:
2.7
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: 4 h exposure duration
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean over 24, 48, and 72 h
Score:
2.7
Max. score:
4
Reversibility:
fully reversible within: 9 days
Remarks on result:
other: 1 h exposure duration; scaling on days 5-10
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean over 24, 48, and 72 h
Score:
2.7
Max. score:
4
Reversibility:
fully reversible within: 10 days
Remarks on result:
other: 1 h exposure duration; scaling on days 8-12
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean over 24, 48, and 72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: 1 h exposure duration; scaling on days 7-12
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: mean over 24, 48, and 72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: 1 h exposure duration
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: mean over 24, 48, and 72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 9 days
Remarks on result:
other: 1 h exposure duration
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: mean over 24, 48, and 72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 6 days
Remarks on result:
other: 1 h exposure duration
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean over 24, 48, and 72 h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 6 days
Remarks on result:
other: 3 min exposure duration
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean over 24, 48, and 72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: 3 min exposure duration; scaling on days 6-8
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean over 24, 48, and 72 h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 6 days
Remarks on result:
other: 3 min exposure duration; scaling on days 6-12
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: mean over 24, 48, and 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: 3 min exposure duration
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: mean over 24, 48, and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: 3 min exposure duration
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: mean over 24, 48, and 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 5 days
Remarks on result:
other: 3 min exposure duration
Other effects:
After 4 h of exposure, the mean erythema score for all animals over 24, 48, and 72 h was 3.1, with one animal showing the max. score of 4. The effect was fully reversible in two animals within 7 and 9 days, respectively, whereas in the third animal the erythema score of 4 persisted until study termination. The mean oedema score after 4 h of treatment was 2.2, with a max. score of 4 in one animal after 24 h. Oedema were fully reversible within 7, 8, and 13 days, respectively. After 1 h of exposure, the mean erythema and oedema scores of all three animals over 24, 48, and 72 h were 2.7 and 2.0, respectively, with erythema scores never exceeding a score of 3 and oedema never exceeding a score of 2 in any of the animals. On day 10 following exposure none of the animals showed any skin reactions on this test site. Exposure to the test item for 3 min revealed mean erythema and oedema scores of 1.4 and 0.4, respectively, whereas erythema never exceeded a score of 2 and oedema never exceeded a score of 1. On day 8 of the observation period neither erythema nor oedema were observed in any of the animals at this test site. As other skin reactions scaling was observed in 2/3, 3/3, and 2/3 animals after 4 h, 1 h, and 3 min of exposure, respectively. Echar formation was observed only in 1/3 animals after 4 h of treatment, but in none animal after 1 h and 3 min of exposure. There were no findings in any of the animals at any test site suggesting corrosiveness of the test item. No skin reactions were observed in any animal on the control site. There were no abnormalities in the general condition and the body weight development of any animal during the observation period.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS Category 2 (H315) according to Regulation (EC) No 1272/2008