Reaction mass of Octyl-3-[3-tert-butyl-4-hydroxy-5-(5-chloro-2H-benzotriazole-2-yl)phenyl]propionate and 2-Ethylhexyl-3-[3-tert-butyl-4-hydroxy-5-(5-chloro-2H-benzotriazole-2-yl)phenyl]propionate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From April 6, 1981 to April 15, 1981

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:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: the 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.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of Octyl-3-[3-tert-butyl-4-hydroxy-5-(5-chloro-2H-benzotriazole-2-yl)phenyl]propionate and 2-Ethylhexyl-3-[3-tert-butyl-4-hydroxy-5-(5-chloro-2H-benzotriazole-2-yl)phenyl]propionate

EC Number:

916-914-6

Molecular formula:

C27H36ClN3O3

IUPAC Name:

Reaction mass of Octyl-3-[3-tert-butyl-4-hydroxy-5-(5-chloro-2H-benzotriazole-2-yl)phenyl]propionate and 2-Ethylhexyl-3-[3-tert-butyl-4-hydroxy-5-(5-chloro-2H-benzotriazole-2-yl)phenyl]propionate

Test material form:

liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

- Weight at study initiation: 2 to 3 kg
- Housing: individually in metal cages
- Water: ad libitum
- Acclimation period: a minimum 4 days
- Temperature (°C): 22 ± 2 °C
- Humidity (%): 55 ± 10%
- Photoperiod: 12hrs light cycle day

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

- Amount(s) applied (volume or weight with unit): 0.5 mL of the test material

Duration of treatment / exposure:

24 hour

Observation period:

24 hours, 48 hours, 72 hours, 4 days and 7 days after the patches removal

Number of animals:

For male: three
For female: three

Details on study design:

- Area of exposure: the prepared abraded and intact skin

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

1.6

Max. score:

2

Remarks on result:

probability of weak irritation

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.3

Max. score:

2

Remarks on result:

positive indication of irritation

Results 3

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24/72 h

Score:

1.9

Max. score:

3.3

Remarks on result:

probability of weak irritation

Results 4

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24/48/72 h

Score:

1.8

Max. score:

4

Remarks on result:

probability of weak irritation

Any other information on results incl. tables

Table 1. Calculation of the primary skin irritation index

Time after exposure hours	Mean reaction score
	Erythema		Edema
	Intact skin	Abraded skin	Intact skin	Abraded skin
24	1.5	1.8	0.3	0.5
72	1.5	1.5	0.3	0.3
Primary Irritation Index (PII)* = 1.9

* 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. (FHSLA § 191.11)

 

Assessment of irritation

0

0.1-1.0 = minimal

1.1-2.0 = slight

2.1-4.0 = moderate

4.1-6.0 = marked

6.1-8.0 = extreme

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

According to U.S. EPA § 163.81-5, Federal Register, Vol. 43, No. 163 (1978) and assessment of irritation, the PII for TK 12871 was 1.9 and TK 12871 was found to cause a slight irritation when applied to intact and abraded rabbit skin. Therefore, TK 12871 was not met a category based on GHS criteria.

Executive summary:

This test using the procedures outlined in the CIBA-GEIGY Study Plan for 810283 and U.S. EPA § 163.81-5, Federal Register, Vol. 43, No. 163 (1978). The sites were grades for erythema and edema at 24 hours, 48 hours, 72 hours, 4 days and 7 days after the patches removal. The Primary Irritation Index for TK 12871 was calculated to be 1.9. On the basis of the test results given above and according toassessment of irritation, TK 12871 was found to cause a slight irritation when applied to intact and abraded rabbit skin.