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

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From April 6, 1981 to April 14, 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 United States Environmental Protection Agency (EPA) § 163.81-4 "Primary eye 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 / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

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

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

- Amount(s) applied (volume or weight with unit): 0.1 mL

Observation period (in vivo):

day 1, 2, 3, 4 and 7

Number of animals or in vitro replicates:

For male: three
For female: three

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: #103, 104, 105, 106 107, 108

Remarks:

Not rinsed: #103, 104 and 105; rinsed: #106, 107 and 108

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

animal: #103, 104, 105, 106 107, 108

Remarks:

Not rinsed: #103, 104 and 105; rinsed: #106, 107 and 108

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal: #105

Remarks:

Not rinsed

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal: #103, 104, 106, 107, 108

Remarks:

Not rinsed: #103 and 104; rinsed: #106, 107 and 108

Time point:

24/48/72 h

Score:

0.66

Remarks on result:

probability of weak irritation

Results 5

Irritation parameter:

chemosis score

Basis:

animal: #103, 104, 105, 107, 108

Remarks:

Not rinsed: #103, 104 and 105; rinsed: #107 and 108

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

chemosis score

Basis:

animal: #106

Remarks:

Rinsed

Time point:

24/48/72 h

Score:

0.33

Remarks on result:

probability of weak irritation

Any other information on results incl. tables

Table 1. Calculation of the primary eye irritation index

Time after exposure days	Mean reaction score
	Unrinsed eyes (A)			Rinsed eyes (B)
	cornea	iris	conjunctive	cornea	iris	conjunctive
1	0	0	2.7	0	0	3.3
2	0	0	0	0	0	1.3
3	0	0	0	0	0	0
4	0	0	0	0	0	0
7	0	0	0.7	0	0	0
Subtotal	0	0	3.4	0	0	4.6
Ttotal	3.4			4.6
Primary irritation index*	0.7			0.9

*The mean reaction scores for cornea, iris and conjunctiva observed after 1, 2, 3, 4 and 7 days were summed up and the sum divided by 5.

 

Index         0            =   none

                 0.1 - 10.9     =   minimal

                 11.0 - 25.9   =   slight

                 26.0 - 55.9   =   moderate

                 56.0 - 84.0   =   marked

                 above 84.0   =   extreme

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

According to U.S. EPA § 163.81-4, Federal Register, Vol. 43, No. 163 (1978), TK 12871 was found to cause a minimal irritation when applied to the rabbit eye mucosa. 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 810282 and U.S. EPA § 163.81-4, Federal Register, Vol. 43, No. 163 (1978). The test material in an amount of 0.1 ml was inserted into the conjunctival sac of the left eye of the rabbits and the lids were gently closed for a few seconds. The right eye was not treated and served as an untreated control. In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of physiological saline. The eye irritation was appraised with a slit-lamp on day 1, 2, 3, 4 and 7 and was scored for each individual rabbit. TK 12871 was found to cause a minimal irritation (primary irritation index 0.7) when applied to the rabbit eye mucosa. When the application site was rinsed, the irritation was found to be minimal (primary irritation index 0.9).