Benzophenone

Endpoint summary

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:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Test method similar to OECD 406. No GLP.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

GLP compliance:

no

Type of study:

guinea pig maximisation test

Species:

guinea pig

Strain:

Hartley

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 400 g

Route:

intradermal and epicutaneous

Vehicle:

olive oil

Concentration / amount:

Induction: 1 and 10%; Challange: 1 and 5%

Route:

epicutaneous, open

Vehicle:

olive oil

Concentration / amount:

Induction: 1 and 10%; Challange: 1 and 5%

No. of animals per dose:

20 female guinea pigs

Details on study design:

MAIN STUDY
- INDUCTION EXPOSURE
- No. of exposures: 2 dermal injections per test group, one week later 1 dermal aplication
- Exposure period: 48 h (dermal application)
- Test groups: Test substance, test substance + FCA, FCA
- Control group: No data
- Concentrations:
Intradermal: Test substance in olive oil (1%), FCA 50% in distilled water, test substance in FCA (1%)
Dermal: 10% concentration

- CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 2 weeks after dermal induction (day 21)
- Exposure period: 48 hours
- Test groups: Test substance
- Control group: No data
- Site: Same as dermal induction
- Concentrations: 1 and 5%
- Evaluation (hr after challenge): 24 and 48 hours

Note: FCA = Freund's complete adjuvant

Positive control substance(s):

no

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

1 and 5%

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: 1 and 5% . No with. + reactions: 0.0. Total no. in groups: 20.0.

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

1 and 5%

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: 1 and 5%. No with. + reactions: 0.0. Total no. in groups: 20.0.

.

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Benzophenone was determined to be non-sensitizer to the skin in a Guinea Pig Maximization Test.

Executive summary:

A Guinea Pig Maximization test was performed with benzophenone in accordance with Magnusson & Kligman method (1970), test method equivalent to OECD 406. 20 Guinea pigs were exposed to the test item during the induction and challenge steps.

Induction consisted of two stages, intradermal injection followed one week later by a 48 h occluded patch application. A total of 6 intradermal injections were administered. They comprised: 2 injections of test substance in olive oil (1%), 2 injections of FCA 50% in distilled water and 2 injections of test substance in FCA (1%). The topical induction concentration were 10%. Fourteen days after topical induction animals were challenged with 1 and 5% test material in olive oil. The treatment sites were examined for evidence of sensitization after patch removal. No sensitization reactions were observed. Therefore, benzophenone was considered to be non-sensitizer to the skin.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (sensitising)

Additional information:

Key study: A Guinea Pig Maximization test was performed with benzophenone in accordance with a test method equivalent to OECD 406. No sensitization reactions were observed and the test item was considered to be non-sensitizer to the skin.

Supporting study: A modified Draize procedure was used to test the potential to induce allergic contact dermatitis in guinea pigs. Benzophenone did not show a sensitizing effect in guinea pigs under the test conditions.

Migrated from Short description of key information:
Key study: Test method equivalent to OECD 406. Non-sensitizer to the skin.
Supporting study: A modified Draize procedure. Non-sensitizer to the skin.

Justification for selection of skin sensitisation endpoint:
Only one reliable study available.