Registration Dossier

Administrative data

Description of key information

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: Experimental data from a human repeat insult patch test. Detailed information on methods and results not available
Qualifier:
no guideline followed
Principles of method if other than guideline:
Human Repeat Insult Patch Test
GLP compliance:
not specified
Type of study:
patch test
Justification for non-LLNA method:
Study undertaken prior to the introduction of the LLNA (OECD TG 429 originally adopted April 2002)
Species:
human
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
No data
Route:
epicutaneous, occlusive
Vehicle:
no data
Concentration / amount:
no data
Route:
epicutaneous, occlusive
Vehicle:
no data
Concentration / amount:
no data
No. of animals per dose:
53 subjects
Details on study design:
No data
Challenge controls:
No data
Positive control substance(s):
not specified
Positive control results:
No data
Key result
Reading:
other: No data
Group:
test group
Dose level:
No data
No. with + reactions:
34
Total no. in group:
53
Remarks on result:
positive indication of skin sensitisation
Reading:
other: n/a
Group:
negative control
Dose level:
n/a
Remarks on result:
not measured/tested
Remarks:
Human repeat insult patch test - No negative control group
Reading:
other: n/a
Group:
positive control
Dose level:
n/a
Remarks on result:
not measured/tested
Remarks:
Human repeat insult patch tests - No positive control
Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The substance is a skin sensitiser
Executive summary:

Skin sensitisation has been investigated in a human repeat insult patch test. A total of 34 of 53 subjects showed skin reaction during induction and challenge

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

There is no available information on animals. Information from a human repeat insult patch test indicate that the substance should be classified as skin sensitising cat.1 according to CLP (1272/2008/EC).


Migrated from Short description of key information:
Human repeat insult patch test: Positive

Justification for selection of skin sensitisation endpoint:
Single documented study available

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

There is no available information on animals. Rosenman etal (Scand J Work Environ Health 13(2): 150 -154, 1987) describe occupational asthma associated with IgE mediated sensitisation occurring in the workplace with a causal association with exposure to himic anhydride, a close structural analogue of the substance.

Allergic reactions of the skin and allergic respiratory reactions are known effects of occupational exposure to cyclic acid anhydrides (Concise International Chemical Assessment Document 75 - Cyclic Acid Anhydrides: Human Health Aspects,World Health Organization, 2009). There is no information to suggest that this substance will not exhibit similar properties.


Migrated from Short description of key information:
There is no available information on animals. Several occupational sensitisation cases by inhalation at processing sites have been reported for a number of cyclic anhydrides which are classified due to human case reports and due to their chemical structure as skin sensitising cat.1 and respiratory sensitising cat.1 according to CLP (1272/2008/EC).

Justification for classification or non-classification

The substance is classified as skin sensitising cat.1 and respiratory sensitising cat.1 according to Regulation 1272/2008/EC (CLP) and Xn, R42/43 (May cause sensitisation by inhalation and skin contact) according to Directive 67/548/EEC (DSD).