2',3-bis[[3-[3,5-di-tert-butyl-4-hydroxyphenyl]propionyl]]propionohydrazide

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: EPA, §163.81-4"Primary eye irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

, number of animals used was 6 instead of 3.

GLP compliance:

no

Remarks:

Quality Assurance Unit statement was given.

Test material

Test material information

Constituent 1

Reference substance name:

2',3-bis[[3-[3,5-di-tert-butyl-4-hydroxyphenyl]propionyl]]propionohydrazide

EC Number:

251-156-3

EC Name:

2',3-bis[[3-[3,5-di-tert-butyl-4-hydroxyphenyl]propionyl]]propionohydrazide

Cas Number:

32687-78-8

Molecular formula:

C34H52N2O4

IUPAC Name:

3-(3,5-di-tert-butyl-4-hydroxyphenyl)-N'-[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoyl]propanehydrazide

Details on test material:

-Physical appearance: white powder

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Ciba-Geigy
- Weight at study initiation: 2-3 kg
- Housing: single housing in metal cages
- Diet: standard rabbit food - NAFAG, No. 814, Gossau SG, ad libitum
- Water: ad libitum
- Acclimation period: at least 4 days

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

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated right eye

Amount / concentration applied:

Test material: 0.1 g

Duration of treatment / exposure:

3 animals: single treatment, rinsing after 30 seconds
3 animals: single treatment, no rinsing

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

3 animals (with rinsing)
3 animals (no rinsing)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: with 10 ml lukewarm water (in 3/6 animals)
- Time after start of exposure: 30 seconds

Scoring system: Draize scoring system

TOOL USED TO ASSESS SCORE: hand-slit lamp

Study design
Amounts of 0.1 g of the test substance were introduced into the conjunctival sac of the left eye with a spatula. After application, they eyelids were heldopen for a few seconds. The right eye served as a control. The treated eyes of three rabbits were each rinsed with 10 ml lukewarm water about 30 seconds after treatment.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24-72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other: without rinsing

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24-72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Remarks on result:

other: without rinsing

Results 3

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24-72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other: without rinsing

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 24-72 h

Score:

0

Max. score:

3

Reversibility:

other: not applicable

Remarks on result:

other: without rinsing

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 24-72 h

Score:

0

Max. score:

3

Reversibility:

other: not applicable

Remarks on result:

other: without rinsing

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: 24-72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 h

Remarks on result:

other: without rinsing

Results 7

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24-72 h

Score:

0.1

Max. score:

3

Reversibility:

fully reversible within: 48 h

Remarks on result:

other: without rinsing

Irritant / corrosive response data:

In the 3 animals where the test substance was rinsed after 30 seconds, no findings were observed within the whole observation period. Without rinsing 1/3 animals showed a conjunctivae score of 1 after 24 h, which was reversible within 48 h. No other effects were observed.

Any other information on results incl. tables

Table 1: Eye irritation scores of treated animals without rinsing at 24 h, 48 h, and 72 h.

		24 h			48 h			72 h
	Rabbit No.	111	112	113	111	112	113	111	112	113
Cornea	Opacity	0	0	0	0	0	0	0	0	0
	Area	0	0	0	0	0	0	0	0	0
Iris	Iris	0	0	0	0	0	0	0	0	0
Conjunctivae	Redness	0	0	1	0	0	0	0	0	0
	Chemosis	0	0	0	0	0	0	0	0	0
	Discharge	0	0	2	0	0	1	0	0	0

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this experiment the test material was found to to be not irritating to the rabbit eye mucosa.

Executive summary:

The substance was tested on 6 New Zealand White rabbits (3 males/3 females) according to the Proposed Guidelines of the United States Environmental Protection Agency (EPA) §163.81-4 "Primary eye irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978. Amounts of 0.1 g of the test substance were introduced into the conjunctival sac of the left eye with a spatula. After application, they eyelids were held open for a few seconds. The right eye served as a control. The treated eyes of three rabbits were each rinsed with 10 ml lukewarm water about 30 seconds after treatment. The reactions were appraised with a slit-lamp after 24 hours and after 2, 3, 4 and 7 days. The eyes were scored daily from 24 h until day 4 and again at 7 d after begin of treatment. No findings regarding cornea, iris or chemosis were observed within the whole study period in animals without rinsing of test substance. Slight redness was observed in 1/3 animals (score: 0.3; 24 -72 h), which was fully reversible within 48 h. Thus, the test substance has no potential as an eye irritant.