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Toxicological information

Skin sensitisation

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Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
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.

Test material

Constituent 1
Chemical structure
Reference substance name:
Bis(2-ethylhexyl) tetrabromophthalate
EC Number:
247-426-5
EC Name:
Bis(2-ethylhexyl) tetrabromophthalate
Cas Number:
26040-51-7
Molecular formula:
C24H34Br4O4
IUPAC Name:
bis(2-ethylhexyl) tetrabromophthalate
Test material form:
liquid
Details on test material:
RC 9927 (batch 6159-199-3), also identified as FR-45B, a slightly turbid, viscous pale yellow liquid received from Pennwalt Corporation on 1st September 1986.

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
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
Challengeopen allclose all
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

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
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

Any other information on results incl. tables

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.

Applicant's summary and conclusion

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.