Registration Dossier

Administrative data

Endpoint:
health surveillance data
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Study period:
Jan 2002 - February 2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: a small study carried out using a large proportion of the working population, a deficiency was that the study only considered workers in the UK factories of the study sponsors.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Study type:
medical screening
Endpoint addressed:
skin sensitisation
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
clinical examination of workforce by expert dermatologist
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
amporphous glass fibre formed from the melting and fiberisation of predominately slilcon dioxide, calcium oxide, magnesium oxide
EC Number:
610-130-5
Cas Number:
436083-99-7
Molecular formula:
Amorphous glass consisting of SinO(3n-1)2(n-1) Polymeric anions ionically bonded to Ca2+ and Mg2+ cations or other alkaline earth cations
IUPAC Name:
amporphous glass fibre formed from the melting and fiberisation of predominately slilcon dioxide, calcium oxide, magnesium oxide
Details on test material:
- Name of test material (as cited in study report): Isofrax, Carbawool(sic)

Method

Type of population:
occupational
Ethical approval:
confirmed, but no further information available
Details on study design:
questionnaire and full clinical examination

Results and discussion

Any other information on results incl. tables

table 2: skin disease findings

Incidental Finding of skin disease amongst those not complaining of skin problems:

*

Contact Dermatitis under Leather Watch Strap

*

Viral wart right index finger

*

Mild pityriasis capitis

*

pityrosporum folliculitis in scalp body and limbs

*

keratosis pilaris on the arms and lymphoedema of leg post DVT

*

Seborrhoeic dermatitis of face chest and scalp

*

Blue naevus in the scalp/organoid naevus in the scalp

*

multiple naevi

*

plantar wart right heel

*

two warts right hand

*

skin tag in axillae

*

skin tags in axillae and neck

 

Table 3: profile of when itch first started

Site

Duration

Findings on Examination

Arms/Face

Few Days

Nil

Arms

Few Days

Nil

Neck Arms Face

2 to 3 weeks

Nil

Face Arms

2 to 3 weeks

Nil

Forearms

2 months

Psoriasis

Neck Arms Legs

2 weeks

Acne

 

Applicant's summary and conclusion