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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
August 3, 1981 - August 10, 1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions (limited documentation, no data on test substance purity, occlusive conditions, 24 h exposure)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
(limited documentation, occlusive treatment, 24 h exposure)
Qualifier:
according to guideline
Guideline:
other: (Proposed Guidelines of the United States Environmental Agency (EPA), §163.81-5 "Primary dermal irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978).
Principles of method if other than guideline:
Gauze patches of 2.5 x 2.5 cm laden with 0.5 mL of the test material were applied to the prepared abdraded and intact skin for 24 hours. Scoring was recorded 24 h, 48 h, 72 h, 4 d and 7 d after application.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of 1H-Benzotriazole-1-methanamine, N,N-bis(2-ethylhexyl)-6-methyl- and 2H-Benzotriazole-2-methanamine, N,N-bis(2-ethylhexyl)-5-methyl- and N,N-bis(2-ethylhexyl)-4-methyl-1H-benzotriazole-1-methylamine and 2H-Benzotriazole-2-methanamine, N,N-bis(2-ethylhexyl)-4-methyl- and N,N-bis(2-ethylhexyl)-5-methyl-1H-benzotriazole-1-methylamine
EC Number:
939-700-4
Molecular formula:
Unspecified
IUPAC Name:
Reaction mass of 1H-Benzotriazole-1-methanamine, N,N-bis(2-ethylhexyl)-6-methyl- and 2H-Benzotriazole-2-methanamine, N,N-bis(2-ethylhexyl)-5-methyl- and N,N-bis(2-ethylhexyl)-4-methyl-1H-benzotriazole-1-methylamine and 2H-Benzotriazole-2-methanamine, N,N-bis(2-ethylhexyl)-4-methyl- and N,N-bis(2-ethylhexyl)-5-methyl-1H-benzotriazole-1-methylamine
Details on test material:
- Analytical purity: no data
- Physical state: liquid (brown)

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: bred and raised in Ciba-Geigy premises
- Age at study initiation: adult
- Weight at study initiation: 2-3 kg
- Housing: housed individually in metal cages
- Diet (e.g. ad libitum): standard rabbit food (NAFAG, No. 814, Gossau SG); ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum of 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%): 55 ± 10%
- Photoperiod (hrs dark / hrs light): 12/ 12

Test system

Type of coverage:
occlusive
Preparation of test site:
other: abraded and intact skin
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL of test material on gauze patches of 2.5 x 2.5 cm
Duration of treatment / exposure:
24h
Observation period:
7 days
Number of animals:
6 (3 males and 3 females)
Details on study design:
TEST SITE
- Site of exposure: back and flank of the rabbits
- Area of exposure: 2.5 x 2.5 cm²
- Type of wrap if used: gauze patches covered with an impermeable material, fastened to the body of the rabbits with adhesive tape

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24h

SCORING SYSTEM:
- Evaluation was performed according to the Draize Scoring System.
- Calculation of the primary skin irritation index: the scores read after 24 and 72 hours for erythema and edema for the intact as well as for the abraded skin were summed up and divided by 4.
- Assessment of irritation:
0
0.0-1.0 : minimal
1.1-2.0 : slight
2.1-4.0 : moderate
4.1-6.0 : marked
6.1-8.0 : extreme

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
Max. score:
4
Reversibility:
not reversible
Remarks:
within 7 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
3.33
Max. score:
4
Reversibility:
not reversible
Remarks:
within 7 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 h
Score:
2.67
Max. score:
4
Reversibility:
not reversible
Remarks:
within 7 days
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: mean over 24, 48 and 72 h
Score:
2.67
Max. score:
4
Reversibility:
not reversible
Remarks:
within 7 days
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
other: mean over 24, 48 and 72 h
Score:
2.33
Max. score:
4
Reversibility:
not reversible
Remarks:
within 7 days
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
other: mean over 24, 48 and 72 h
Score:
2.33
Max. score:
4
Reversibility:
not reversible
Remarks:
within 7 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks:
within 7 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks:
within 7 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks:
within 7 days
Irritation parameter:
edema score
Basis:
animal #4
Time point:
other: mean over 24, 48 and 72 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks:
within 7 days
Irritation parameter:
edema score
Basis:
animal #5
Time point:
other: mean over 24, 48 and 72 h
Score:
1.67
Max. score:
4
Reversibility:
not reversible
Remarks:
within 7 days
Irritation parameter:
edema score
Basis:
animal #6
Time point:
other: mean over 24, 48 and 72 h
Score:
1
Max. score:
4
Reversibility:
not reversible
Remarks:
within 7 days

Any other information on results incl. tables

Results of Skin irritation (intact skin, 24 h exposure):

Observation time

Rabbit no.

1

2

3

4

5

6

Ery.

Edema

Ery.

Edema

Ery.

Edema

Ery.

Edema

Ery.

Edema

Ery.

Edema

24 h

2

3

2

3

2

3

2

3

2

1

2

1

48 h

2

3

4

3

3

3

2

3

2

2

2

1

72 h

2

3

4

3

3

3

4

3

3

2

3

1

4 d

2

3

4

3

3

2

4

2

2

2

3

2

7 d

2

3

3

3

3

2

3

3

3

2

3

2

Mean value 24 + 48 + 72 h

2.00

3.00

3.33

3.00

2.67

3.00

2.67

3.00

2.33

1.67

2.33

1.00

Mean value 24 + 48 + 72 h all animals

2.55

2.44

-

-

-

-

-

-

-

-

-

-

Ery.: Erythema

 

Mean reaction scores:

 

Mean reaction score

 

Time after exposure (hours)

Erythema

Edema

Total

Intact skin

Abraded skin

Intact skin

Abraded skin

24

2.0

2.3

2.3

2.7

 

72

3.2

3.3

2.5

2.7

 

Total

5.2

5.6

4.8

5.8

21

Primary irritation index = 21.0 / 4 = 5.3

The test substance caused a marked irritation when applied to intact and abraded rabbit skin.

Up to 4 days after application, the surface of the erythema was greater than the site of application.

Slightly ischaemic areas were observed after 48 hours in 4/12 and after 3 and 4 days in 10/12 application sites.

After 7 days, practically all animals had cracked skin.

Both erythema and edema were observed with an average score between 2 and 3 (24 to 72h). The skin condition did not improve on day 4 and only barely improved on day 7, which was the last observation time point. The results for abraded skin were not considered for classification.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information
Conclusions:
The test article was found to cause a marked irritation when applied to intact and abraded rabbit skin.