Bis(2-ethylhexyl) tetrabromophthalate

Endpoint summary

Description of key information

A valid skin irritation/corrosion study according OECD 404 and valid eye irritation study according OECD 405 are available.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Principles of method if other than guideline:

The potential of RC9927 to cause inflammatory or corrosive changes upon first contact with skin was assessed by semi-occluded application of 0.5 ml of the test material to the closely-clipped dorsa of 3 male and 3 female New Zealand White rabbits for four hours. Dermal reactions were assessed according to Draize 1, 24, 48 and 72 hours after removal of the dressings.

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3 male and 3 female animals

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.2

Max. score:

4

Reversibility:

fully reversible within: 2 days

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable, score = 0 at any time point

Very slight erythema was observed at 3 test sites one hour after removal of the dressings, and in one animal only at the 24 -hour examination. No other changes were apparent.

all dermal irritation responses had resolved by the 48 -hour examination.

The control sites did not show any response to the control procedure.

Interpretation of results:

GHS criteria not met

Executive summary:

The potential of RC9927 to cause inflammatory or corrosive changes upon first contact with skin was assessed by semi-occluded application of 0.5 ml of the testmaterial to the closely-clipped dorsa of 3 male and 3 female New Zealand White rabbits for four hours. Dermal reactions were assessedaccording to Draize 1, 24, 48 and 72 hours after removal of the dressings.

Very slight erythema was observed at 3 test sites one hour after removal of the dressings, and in one animal only at the 24 -hour examination. No other changes were apparent. All dermal irritation responses had resolved by the 48 -hour examination.

The control sites did not show any response to the control procedure.

Under the conditions of this test, RC9927 was not irritating to the skin.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Principles of method if other than guideline:

The potential of RC9927 to cause damage to the conjunctivae, iris or cornea was assessed in 3 male and 3 female New Zealand White rabbits, each subject to single ocular instillation of 0.1 ml of the test material. Ocular reactions were examined 1, 24, 48 and 72 hours after treatment according to Draize.

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Vehicle:

unchanged (no vehicle)

Controls:

not required

Duration of treatment / exposure:

72 hours (no information if eyes were washed)

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

3 male and 3 female animals

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable, score = 0 at any time point

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable, score = 0 at any time point

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: not applicable, score = 0 at any time point

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable, score = 0 at any time point

A crimson-red appearance to the conjunctiva or slight injection of the conjunctival blood vessels and an ocular discharge, were observed among the rabbits one hour after instillation of RC9927. No other change was apparent. All ocular irritation responses had resolved by the 24-hour examination.

Interpretation of results:

GHS criteria not met

Executive summary:

The potential of RC9927 to cause damage to the conjunctivae, iris or corneawas assessed in 3 male and 3 female New Zealand White rabbits, each subject to single ocular instillation of 0.1 ml of the test material. Ocular reactions were examined 1, 24, 48 and 72 hours after treatment according to Draize.

A crimson-red appearance to the conjunctiva or slight injection of the conjunctival blood vessels and an ocular discharge, were

observed among the rabbi ts one hour after instillation of RC9927. No other change was apparent. All ocular irritation responses had resolved by the 24-hour examination.

Under the conditions of this test, RC9927 was not irritating to the eye.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

In the skin irritation study an erythema score of 0.2 of 4 according Draize was determined after 24, 48 and 72 hours. The effect is fully reversible within 2 days. The edema score was 0 of 4 after 24, 48 and 72 hours.

In the eye irritation study the cornea, iris, conjunctivae and chemosis score according Draize was 0 after 24, 48 and 72 hours.

Justification for classification or non-classification

In the skin irritation/corrosion and eye irritation studies bis(2-ethylhexyl) tetrabromophthalate was not irritating. According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.