Registration Dossier

Administrative data

Endpoint:
respiratory sensitisation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study not conducted to GLP or standardised guidelines, however it remains well reported and of adequate design for its purpose

Data source

Reference
Reference Type:
secondary source
Title:
Unnamed
Year:
2008

Materials and methods

Principles of method if other than guideline:
Guinea pigs were administered hydroxylammonium sulphate via intradermal injection (5% in water) on day 1 and topical application on day 7 (10% in water). Animals were initially challenged by topical application (10% in water) on day 21. Animals were rechallenged with the test chemical via inhalation at doses of 0.0065 or 0.0132 mg/l for 30 minutes or via the intratracheal route at doses of either 5, 15, 25 and 75 mg/kg. Breathing rates were measured during exposure and 60 minutes after exposure.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
No data

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
No data

Test system

Route of induction exposure:
other: Intradermal and topical
Route of challenge exposure:
other: Inhalation and intratracheal
Vehicle:
not specified
Concentration:
Inhalation: 0.0065 mg/l and 0.0132 mg/l
Intratracheal: 5, 15, 25 and 75 mg/kg
No. of animals per dose:
4
Details on study design:
Guinea pigs were administered hydroxylammonium sulphate via intradermal injection (5% in water) on day 1 and topical application on day 7 (10% in water). Animals were initially challenged by topical application (10% in water) on day 21. Animals were rechallenged with the test chemical via inhalation at doses of 0.0065 or 0.0132 mg/l for 30 minutes or via the intracheal route at doses of either 5, 15, 25 and 75 mg/kg. Breathing rates were measured during exposure and 60 minutes after exposure.
Challenge controls:
No data

Results and discussion

Results:
There was no increase in breathing rates during either the administration period or 60 minutes after the exposure. The authors considered an alteration in breathing rates as an indication of pulmonary sensitisation.
Positive control results:
No data
Negative control results:
no data

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Conclusions:
Hydroxylammonium sulphate did not cause respiratory tract irritation in guinea pigs after induction via intradermal and topical application.
Executive summary:

In a respiratory tract sensitisation study, guinea pigs were administered hydroxylammonium sulphate via intradermal (5% in water) and topical application (10% in water) on day 1 and 7, respectively, as part of the induction process. Animals were initially challenged by topical application (10% in water) on day 21. Animals were rechallenged with the test chemical via inhalation at doses of 0.0065 or 0.0132 mg/l for 30 minutes or via the intracheal route at doses of either 5, 15, 25 and 75 mg/kg. Breathing rates remained unchanged during the treatment period and for 60 minutes after the exposure which the authors considered to a be an indication that no pulmonary sensitisation had occurred. Hydroxylammonium sulphate was therefore considered to not cause respiratory tract sensitisation in guinea pigs by this study design.