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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.