complex reaction mass of Chinese gum rosin post reacted with acrylic acid

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

434-230-1

EC Name:

-

Cas Number:

144413-22-9

Molecular formula:

Not applicable - the substance is an UVCB

IUPAC Name:

1,4a-dimethyl-7-(propan-2-yl)-1,2,3,4,4a,4b,5,6,10,10a-decahydrophenanthrene-1-carboxylic acid; prop-2-enoic acid

Test material form:

other: pale yellow blocks

Details on test material:

- Chemical name: Rosin acid reaction products with acrylic acid hydrogenated

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

ANIMALS
Three New Zealand White rabbits, supplied by David Percival Ltd, Moston, Sandbach, Cheshire, UK, were used. At the start of the study the animals
weighed 2.50 to 2.73 kg and were twelve to sixteen weeks old. After a minimum acclimatisation period of five days each animal was given a number
unique within the study which was written with a black indelible marker-pen on the inner surface of the ear and on the cage label.

HUSBANDRY
The animals were individually housed in suspended metal cages. Free access to mains drinking water and food (STANRAB SQC Rabbit Diet, Special Diets Services Ltd, Witham, Essex, UK) was allowed throughout the study.

ENVIRONMENTAL CONDITIONS
The animal room was maintained at a temperature of 18 to 25°C and relative humidity of 65 to 74%. On occasions the temperature and relative humidity were outside the limits specified in the protocol (23°C and 70% respectively). These deviations were considered not to affect the purpose or integrity of the study. The rate of air exchange was approximately fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light and twelve hours darkness.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

90 mg (0.1 mL)

Duration of treatment / exposure:

eyes unrinsed

Observation period (in vivo):

7 d

Number of animals or in vitro replicates:

3

Details on study design:

PROCEDURE

Immediately before the start of the test, both eyes of the provisionally selected test rabbits were examined for evidence of ocular irritation or defect with the aid of a light source from a standard ophthalmoscope. Animals showing evidence of ocular lesions were rejected and replaced.

One rabbit was initially treated. A volume of 0.1 ml of the test material, which was found to weigh approximately 90 mg (as measured by gently compacting the required volume into an adapted syringe) was placed into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball. The upper and lower eyelids were held together for about one second immediately after application, to prevent loss of the test material, and then released. The left eye remained untreated and was used for control purposes. Immediately after administration of the test material, an assessment of the initial pain reaction was made.

After consideration of the ocular responses produced in the first treated animal, two additional animals were treated. In order to minimise pain on application of the test material, one drop of local anaesthetic ("Ophthaine", 0.5% proxymetacaine hydrochloride, E. R. Squibb & Sons Limited, Hounslow, Middlesex, UK) was instilied into both eyes of these animals 1 to 2 minutes before treatment.

Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment, according to the numerical evaluation from Draize J. H. (1977) "Dermal and Eye Toxicity Tests" In: Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy of Sciences, Washington DC, p. 48 to 49.

Any other ocular effects were also noted. Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope.
An additional observation was made on Day 7 to assess the reversibility of the ocular effects.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #1

Remarks:

(No.138)

Time point:

24/48/72 h

Score:

1.7

Max. score:

3

Reversibility:

fully reversible within: 7 d

Results 2

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #2

Remarks:

(No.18)

Time point:

24/48/72 h

Score:

0.7

Max. score:

3

Reversibility:

fully reversible within: 72 h

Results 3

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #3

Remarks:

(No.6)

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72 h

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Remarks:

(No.168)

Time point:

24/48/72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 5

Irritation parameter:

chemosis score

Basis:

animal #2

Remarks:

(No.18)

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 6

Irritation parameter:

chemosis score

Basis:

animal #3

Remarks:

(No.6)

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 7

Irritation parameter:

cornea opacity score

Basis:

animal #1

Remarks:

(No.138)

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 d

Results 8

Irritation parameter:

cornea opacity score

Basis:

animal #2

Remarks:

(No.18)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 9

Irritation parameter:

cornea opacity score

Basis:

animal #3

Remarks:

(No.6)

Time point:

24/48/72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 10

Irritation parameter:

iris score

Basis:

animal #1

Remarks:

(No.138)

Time point:

24/48/72 h

Score:

0.7

Max. score:

2

Reversibility:

fully reversible within: 72 h

Results 11

Irritation parameter:

iris score

Basis:

animal #2

Remarks:

(No.18)

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Results 12

Irritation parameter:

iris score

Basis:

animal #3

Remarks:

(No.6)

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Irritant / corrosive response data:

All changes fully reversible within 7 days, all treated eyes appeared normal at the end of the observation period.

Any other information on results incl. tables

A dulling of the normal lustre of the corneal surface was noted in one treated eye at the 1-hour observation. Diffuse corneal opacity was noted in two treated eyes at the 24 and 48-hour observations and in one treated eye at the 72-hour observation.

Iridial inflammation (grade 1) was noted in two treated eyes at the l-hour observation and persisted in one treated eye at the 24 and 48-hour observations.

Moderate to severe conjunctival irritation was noted in all treated eyes at the 1-hour observation with minimal to moderate conjunctival irritation apparent at the 24 and 48-hour observations. Minimal conjunctival redness was noted in one treated eye at the 72-hour observation.

Treated eyes appeared normal 72 hours or 7 days after treatment.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test material , Arakawa KE-604, produced a maximum group mean score of 17.3 and was classified as a MODERATE IRRITANT (Class 5 on a 1 to 8 scale) to the rabbit eye according to the modified Kay and Calandra classification system.
The test material did not produce positive criteria in any rabbit according to the EU labelling regulations. No symbol and risk phrase are therefore required.

Executive summary:

A study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. The method used followed that described in the OECD Guidelines for Testing of Chemicals No. 405 "Acute Eye Irritation/Corrosion" (adopted 24 February 1987) and Method B5 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC).

The results may be used as a basis for classification and labelling under Annex VI of CounciI Directive 67/548/EEC (as adapted to technical progress by Commission Directive 93/21/EEC) relating to the classification, packaging and labelling of dangerous substances.

A single application of the test material to the non-irrigated eye of three rabbits produced diffuse corneal opacity, iridial inflammation and moderate to severe conjunctival irritation. A dulling of the normal lustre of the corneal surface was also noted. Treated eyes appeared normal 72 hours or 7 days after treatment.

The test material produced a maximum group mean score of 17.3 and was classified as a moderate irritant (Class 5 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.

The test material did not meet the criteria for classification as irritant according to EU labelling regulations. No symbol and risk phrase are required.