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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
During June of 1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study run to a method comparable with current guidelines and to GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
The only differences were that the compound was evaluated on both intact and abraded skin following a 24-hour exposure, rather than only on intact skin followiing a 4-hour exposure as directed in the OECD Guidelines.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
semi-solid (amorphous): gel
Remarks:
migrated information: paste
Details on test material:
Batch No.: 19101-164-1
Purity: not specified

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:
- Age at study initiation:
- Weight at study initiation: 2.71 to 3.11 kg
- Housing:
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum):
- Acclimation period:

Test system

Type of coverage:
occlusive
Preparation of test site:
other: one intacted and one abraded
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
2 males, 1 female
Details on study design:
TEST SITE
- Area of exposure: approximately two inches square
- % coverage: The compound was covered with a 2x2 gauze patch that was also premoistened with deionized water.
- Type of wrap if used:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test sites were gently wiped with a soft cloth and deionized water.
- Time after start of exposure: 24 h
SCORING SYSTEM: Draize, J.H., Woodard, G., and Calvery, H.O.: J. Pharmacol. exptl. Therap., 82:377-390,1944.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: mean of 24, 48 and 72 hours
Score:
ca. 0.22
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Intact skin, one fully reversed within 72 hours, the other two did not appear erythema.
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: mean of 24, 48 and 72 hours
Score:
ca. 0.44
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Abraded skin, two fully reversed within 72 hours, the other one did not appear erythema.
Irritation parameter:
edema score
Basis:
mean
Time point:
other: mean of 24, 48 and 72 hours
Score:
0
Max. score:
0
Remarks on result:
other: Intact skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: mean of 24, 48 and 72 hours
Score:
0
Max. score:
0
Remarks on result:
other: Abraded skin
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: mean of 24 and 72 hours
Score:
0.25
Remarks on result:
other: mean of score in intact and abraded skin
Irritant / corrosive response data:
Following a 24-hour exposure to the compound, very slight (score =1), non-confluent erythema was apparent at both the intavt and the abraded site of one animal and at the abraded site of a second rabbit. No erythema was evident at either site in the third rabbit, and there was no edema at any of the application sites. There was no obvious change at any of the sites at 48 hours post dose. However, by 72 hours post dose, the erythema had subsided completely, and the skin at each intact and abraded site appeared essentially normal.
Other effects:
Throughout the 72-hour observation period, all animals remained alert and active, but the food consumption of one rabbit was reduced. The final body weight of each rabbit was essentially comparable to the animal's pre-test weight.

Any other information on results incl. tables

Individual Skin Reactions Following 24-Hour Exposure

Condition of skin

Observation

period

(hours)

Rabbit No.

1

2

3

Erythema

Edema

Erythema

Edema

Erythema

Edema

Intact

24

1

0

0

0

0

0

48

1

0

0

0

0

0

72

0

0

0

0

0

0

Abraded

24

1

0

0

0

1

0

48

1

0

0

0

1

0

72

0

0

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The results of this reveal that the Primary Irritation Score is 0.25, indicating that the test substance produced only negligible irritation on rabbit skin and is therefore not a primary skin irritant.