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Description of key information

The potential of RC9927 (bis(2-ethylhexyl) tetrabromophthalate) to cause delayed contact hypersensitivity in guinea-pigs was assessed by a modified version of the method of Buehler. No adverse effects was observed (non sensitising).

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
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 406 (Skin Sensitisation)
Principles of method if other than guideline:
The potential of RC9927 to cause delayed contact hypersensitivity in guinea-pigs was assessed by a modified version of the method of Buehler.
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
The study was conducted in 1987. At this time an OECD guideline for a LLNA was not available.
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
induction procedure: application of a 20 x 20 mm absorbent patch soaked with 0.25 ml of undilited test material
challenge procedure: application of a 20 x 20 mm absorbent patch soaked with 0.25 ml of undilited test material
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
induction procedure: application of a 20 x 20 mm absorbent patch soaked with 0.25 ml of undilited test material
challenge procedure: application of a 20 x 20 mm absorbent patch soaked with 0.25 ml of undilited test material
No. of animals per dose:
Test group: 20 animals
Control group: 10 animals
Positive control group: 10 animals
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.25 ml
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. Hours after challenge: 24.0. Group: test group. Dose level: 0.25 ml. No with. + reactions: 0.0. Total no. in groups: 20.0.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.25 ml
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. Hours after challenge: 48.0. Group: test group. Dose level: 0.25 ml. No with. + reactions: 0.0. Total no. in groups: 20.0.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0 ml
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. Hours after challenge: 24.0. Group: negative control. Dose level: 0 ml. No with. + reactions: 0.0. Total no. in groups: 10.0.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0 ml
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. Hours after challenge: 48.0. Group: negative control. Dose level: 0 ml. No with. + reactions: 0.0. Total no. in groups: 10.0.
Key result
Reading:
other:
Hours after challenge:
24
Group:
positive control
Dose level:
0.1% w/v dinitrochlorobenzene
No. with + reactions:
8
Total no. in group:
9
Clinical observations:
erythematous responses
Remarks on result:
positive indication of skin sensitisation

There was no dermal response to occluded application of RC9927 to test group animals at any of the three phases of induction.

There was no significant dermal response to challenge application of the undiluted testmaterial in test or control group animals.

Challenge application of dinitrochlorobenzene elicited significant erythematous responses in eight of the nine surviving positive control guinea-pigs. No significant dermal reaction was observed in the vehicle control group.

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this study, RC9927 (bis(2-ethylhexyl) tetrabromophthalate) was negative in the Bühler assay.
Executive summary:

The potential of RC9927 (bis(2-ethylhexyl) tetrabromophthalate) to cause delayed contact hypersensitivity in guinea-pigs was assessed by a modified version of the method of Buehler.

There was no dermal response to occluded application of RC9927 to test group animals at any of the three phases of induction.

There was no significant dermal response to challenge application of the undiluted testmaterial in test or control group animals.

Challenge application of dinitrochlorobenzene elicited significant erythematous responses in eight of the nine surviving positive control guinea-pigs. No significant dermal reaction was observed in the vehicle control group.

Under the conditions of this study, RC9927 was negative in the Bühler assay.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

No dermal response to occluded application of RC9927 (bis(2-ethylhexyl) tetrabromophthalate) to test group animals at any of the three phases of induction. No significant dermal response to challenge application (1st and 2nd reading: 0 of 20 animals revealed effects) of the undiluted test material in test or control group animals.


Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

No data.


Justification for classification or non-classification

Bis(2-ethylhexyl) tetrabromophthalate was negative in the Bühler test.

According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.