Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
other: human exposure evidence
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)

Data source

Referenceopen allclose all

Reference Type:
other company data
Title:
Unnamed
Year:
1985
Reference Type:
study report
Title:
Unnamed
Year:
2008

Materials and methods

Type of sensitisation studied:
skin
Study type:
survey
Test guideline
Qualifier:
no guideline followed
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Type of population:
occupational
Ethical approval:
not specified
Subjects:
see attached study for further details
Route of administration:
dermal

Results and discussion

Results of examinations:
Anecdotal information relating to skin sensitisation problems on a previous production site (and different legal entity) resulted in an assignment of R43. We have no access to this data. Our own health surveillance has shown no incidences of such sensitisation. However, this may be due to improved RMMs.
Dermal – sensitising – no animal data. Historical human experience but no data. No clinical data but info from HS on staff (T. Swan Occ. Health Review, 2004-2008) shows very low incidence of irritation.


2004 10 personnel, 1 report dermatitis + 1 dry hands (discount), so 10%
2005 10 personnel, 1 report dry hands (discount) + 1 red hands, so 10%
2006 14 personnel, 1 dermatitis report + 1 calloused hand (discount), so 7%
2007 14 personnel, 1 dermatitis report - wrists from o-tolyl biguanide sensitivity (discount), so 0%
2008 17 personnel, 0 reports, so 0%
Contact dermatitis has been reported frequently among rubber workers and even more frequently among users of rubber products. Several NIOSH health hazard evaluations have reported contact dermatitis in tire and nontire plants, but most of the evaluations could not identify a specific chemical as the causative agent. Lack of information about sources of worker exposure including direct contact with bulk chemicals, processed stocks, and machinery contaminated with chemicals has contributed to the difficulty in determining the association between contact dermatitis and specific chemicals (NIOSH, 1993).

Applicant's summary and conclusion

Conclusions:
sensitising