Registration Dossier

Toxicological information

Respiratory sensitisation

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Administrative data

Endpoint:
respiratory sensitisation
Remarks:
other: based on human data
Type of information:
other: Review
Adequacy of study:
weight of evidence
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: MAK review
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Referenceopen allclose all

Reference Type:
review article or handbook
Title:
Unnamed
Year:
2000
Reference Type:
review article or handbook
Title:
Unnamed
Year:
2002

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
not applicable
GLP compliance:
no

Test material

Constituent 1
Details on test material:
no details given

Test animals

Species:
human
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
no details given

Test system

Route of induction exposure:
inhalation
Route of challenge exposure:
inhalation
Vehicle:
not specified
Concentration:
no details given
No. of animals per dose:
no details given
Details on study design:
no details given
Challenge controls:
no details given

Results and discussion

Results:
MTHPA was classified as "Sa", danger of sensitization of airways by the German MAK commission (Commission for the investigation of health hazards of chemical compounds in the work area).
Substances classified as "Sa" can cause symptoms of the airways and also of the conjunctiva (substances causing airway sensitization).
Positive control results:
no details given
Negative control results:
no details given

Any other information on results incl. tables

no details given

Applicant's summary and conclusion

Interpretation of results:
sensitising
Conclusions:
Tetrahydromethylphthalic anhydride (MTHPA) classified as sensitising to the respiratory tract.
Executive summary:
Tetrahydromethylphthalic anhydride (MTHPA) was classified as "Sa", danger of sensitization of airways by the German MAK commission (Commission for the investigation of health hazards of chemical compounds in the work area). Substances classified as "Sa" can cause symptoms of the airways and also of the conjunctiva (substances causing airway sensitization).