1-bromo-4-fluorobenzene

Endpoint summary

Description of key information

Various studies were performed for test chemical 1-Bromo-4-fluorobenzene (CAS No: 460-00-4) to observe its sensitization potential. Based upon the available data for target substance as well as for read across substance and applying weight of evidence approach, the test chemical can be classified as skin sensitizer. Even though the some data for the target chemical suggests that it is not sensitizing, but the majority of data suggest that it is sensitizing. Therefore, the test chemical 1-Bromo-4-fluorobenzene (CAS No: 460-00-4) is classified as a skin sensitizer.

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: data is from review article or handbook

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

Skin sensitization test was conducted in guinea pigs for 1-Bromo-4-fluorobenzene by Magnusson and Kligman guinea pig maximization test.

GLP compliance:

not specified

Type of study:

other: Magnusson and Kligman guinea pig maximization test

Justification for non-LLNA method:

not specified

Species:

guinea pig

Strain:

not specified

Sex:

not specified

Details on test animals and environmental conditions:

No data

Route:

other: no data

Vehicle:

no data

Concentration / amount:

No data

Route:

other: no data

Vehicle:

no data

Concentration / amount:

No data

No. of animals per dose:

No data

Details on study design:

No data

Challenge controls:

No data

Positive control substance(s):

not specified

Reading:

1st reading

Group:

test chemical

Clinical observations:

mild sensitizer

Remarks on result:

other: Reading: 1st reading. Group: test group. Clinical observations: mild sensitizer.

Produced a 20% sensitization rate.

Interpretation of results:

sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test material 1-Bromo-4-fluorobenzene (CAS No: 460-00-4) was observed to be sensitizing on guinea pig skin.

Executive summary:

The Magnusson and Kligman guinea pig maximization test was conducted for test chemical1-Bromo-4-fluorobenzene (CAS No: 460-00-4).

 

Test chemical produced a 20% sensitization rate. Hence1-Bromo-4-fluorobenzene (CAS No: 460-00-4) was considered as mild skin sensitizer to guinea pigs.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (sensitising)

Additional information:

Skin sensitization

Various studies were performed for test chemical 1-Bromo-4-fluorobenzene (CAS No: 460-00-4) to observe its sensitization potential that have been summarized as below;

The skin sensitization study was reported by National Toxicology Program (NTP), National Institute of Environmental Health Sciences (NIEHS) National Institutes of Health U.S Department of Health and Human Services in 2005 for the test chemical 1-Bromo-4-fluorobenzene (CAS No: 460-00-4) in guinea pigs. This study was performed via Magnusson and Kligman guinea pig maximization test.  It was observed that the test chemical produced a 20% sensitization rate. Hence 1-Bromo-4-fluorobenzene (CAS No: 460-00-4) was considered as mild skin sensitizer to guinea pigs.

IFA (GESTIS) 2016 observed skin sensitization effects for test chemical 1-Bromo-4-fluorobenzene (CAS No: 460-00-4) to OECD guideline 406 in guinea pigs. In this study the guinea pigs were induced intradermally with 7% of test chemical. After 7 days animals were induced dermally with 50% of test chemical. Induction as followed by challenge exposure after 2 weeks at concentration of 0.2 %. The induction treatment produced slight irritation but dermal provocation with 0.2 % of test chemical did not.  Hence the test substance1-Bromo-4-fluorobenzene (CAS No: 460-00-4) is considered as non-sensitizing on guinea pigs.

In the study by European Chemical Agency (ECHA) 2013, skin sensitization effects were observed for similar read across substance 1, 4-Dichlorobenzene (CAS No: 106-46-7) in guinea pigs by Magnusson Kligman test.. During the test, the test animals were induced intradermally with 0.1% of 1, 4-Dichlorobenzene and later topically with 25% of 1, 4-Dichlorobenzene. Induction was followed by challenge treatment with 25% of test chemical in petrolatum. Positive controls were also used. At 0.1 % intradermally in a pre-test, slight irritation was observed in the animals. The maximum non-irritating concentration was greater than 25 % as no irritation was observed in a pre-test at 25 % in petrolatum. Minimal signs of irritation (1/24) were observed after induction. Over all, no treated animals were sensitized after 24 h; 21 % were sensitized with scores of 2 and 3 after 48 h (also one of the control animals was considered sensitized with a score of 2). No histological examination was conducted. Hence based upon the overall observations, the test chemical 1, 4-Dichlorobenzene (CAS No: 106-46-7) was concluded as weak sensitizer to guinea pigs.

 

EUROPEAN COMMISSION – European Chemicals Bureau (2000) conducted skin sensitization study to for another similar read across substance 4–chlorotoluene (CAS No: 106–43–4) in guinea pigs according OECD Guide–line 406 ‘Skin Sensitization’. Since the guinea pigs produced known skin sensitizing effects, the test chemical 4–chlorotoluene (CAS No: 106–43–4) can be considered as skin sensitizing to guinea pigs.

Based upon the available data for target substance as well as for read across substance and applying weight of evidence approach, the test chemical can be classified as skin sensitizer. Even though the some data for the target chemical suggests that it is not sensitizing, but the majority of data suggest that it is sensitizing. Therefore, the test chemical 1-Bromo-4-fluorobenzene (CAS No: 460-00-4) is classified as a skin sensitizer.

Migrated from Short description of key information:

The skin sensitization study was reported by National Toxicology Program (NTP), National Institute of Environmental Health Sciences (NIEHS) National Institutes of Health U.S Department of Health and Human Services in 2005 for the test chemical 1-Bromo-4-fluorobenzene (CAS No: 460-00-4) in guinea pigs. This study was performed via Magnusson and Kligman guinea pig maximization test.  It was observed that the test chemical produced a 20% sensitization rate. Hence 1-Bromo-4-fluorobenzene (CAS No: 460-00-4) was considered as mild skin sensitizer to guinea pigs.

Justification for selection of skin sensitisation endpoint:

The skin sensitization study was reported by National Toxicology Program (NTP), National Institute of Environmental Health Sciences (NIEHS) National Institutes of Health U.S Department of Health and Human Services in 2005 for the test chemical 1-Bromo-4-fluorobenzene (CAS No: 460-00-4) in guinea pigs. This study was performed via Magnusson and Kligman guinea pig maximization test.  It was observed that the test chemical produced a 20% sensitization rate. Hence 1-Bromo-4-fluorobenzene (CAS No: 460-00-4) was considered as mild skin sensitizer to guinea pigs.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

The skin sensitization potential of test chemical 1-Bromo-4-fluorobenzene (CAS No: 460-00-4) was observed in various studies. From the results obtained from these studies it is concluded that the chemical 1-Bromo-4-fluorobenzene (CAS No: 460-00-4) is likely to cause skin sensitization and thus can be classified as skin sensitizer.