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

Skin irritation / corrosion

Administrative data

Endpoint:

skin 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 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

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

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system 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 2.75 to 2.80 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 22°C and relative humidity of 65 to 74%. On occasions the relative humidity was above the limit specified in the protocol (70%). This deviation was 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

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

other: distilled water

Controls:

not specified

Amount / concentration applied:

0.5 g

Duration of treatment / exposure:

3 min., 1 h, 4 h

Observation period:

72 h

Number of animals:

3

Details on study design:

PROCEDURE

On the day before the test each rabbit was clipped free of fur from the dorsal flank area using veterinary clippers. Only animals with a healthy intact epidermis by gross observation were selected for the study.

One rabbit was initially treated. Three suitable test sites were selected on the back of the rabbit. At each test site a quantity of 0.5g of the test material, moistened with 0.5 mL of distilled water, was introduced under a 2.5 cm x 2.5 cm cotton gauze patch and placed in position on the shorn skin. Each patch was secured in position with a strip of surgical adhesive tape (BLENDERM: approximate size 2.5 cm x 4.0 cm). To prevent the animal interfering with the patches, the trunk of the rabbit was wrapped in an elasticated corset (TUBIGRIP) and the animal was returned to its cage for the duration of the exposure period.

One patch was removed at each of three time points: 3 minutes, 1 hour and 4 hours after application. Any residual test material was removed by gentle swabbing with cotton wool soaked in distilled water.

After consideration of the skin reactions produced in the first animal, two additional animals were treated with 0.5g moistened test material. One patch was applied to the back of each rabbit, and was allowed to remain in contact with the skin for a period of four hours.

Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation and scored according to the following scale 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.31.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 1 h

Score:

0.7

Max. score:

1

Reversibility:

fully reversible within: 24 h

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 1 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible within: 24 h

Results 3

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

4h Exposure:
Very slight erythema was noted at two treated skin sites at the 1-hour observation. Very slight oedema was noted at one of these treatment sites at this time. One treated skin site appeared normal throughout the study. All treated skin sites appeared normal at the 24-hour observation.
The Primary Irritation Index was 0.

Other effects:

No other effects mentioned.

Any other information on results incl. tables

4-Hour Exposure Period

Very slight erythema was noted at two treated skin sites at the 1-hour observation. Very slight oedema was noted at one of these treatment sites at this time. One treated skin site appeared normal throughout the study. All treated skin sites appeared normal at the 24-hour observation.

1-Hour Exposure Period

No signs of dermal irritation were noted throughout the study.

3-Minute Exposure Period

No signs of dermal irritation were noted throughout the study.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test material, Arakawa KE-604, produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted
The test material did not meet the criteria for classification as irritant or corrosive according to EU labelling regulations. No symbol and risk phrase are required.

Executive summary:

A study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method used followed the recommendations of the OECD Guidelines for Testing of Chemicals No. 404 "Acute Dermal Irritation/Corrosion" (adopted 17 July 1992) and Method B4 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 Council 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 4-hour, semi-occluded application of the test material to the intact skin of three rabbits produced very slight erythema and very slight oedema. No corrosive effects were noted. 3-minute and 1-hour semi-occluded applications of the test material to the intact skin of one rabbit produced no corrosive effects.

The test material produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin according to the Draize classification scheme. The test material did not meet the criteria for classification as irritant or corrosive according to EU labelling regulations. No symbol and risk phrase are required.