Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
The assay is comparable to OECD guideline 406 with some restrictions concerning documentation (e.g. no individual test results). No readings after 24 h but clearly positive results after 48 h. No GLP study.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1084
Report date:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
no readings at 24 hours
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
former test strategy for skin sensisation, more animals are tested compared to LLNA

Test material

Constituent 1
Chemical structure
Reference substance name:
3,3'-methylenebis[5-methyloxazolidine]
EC Number:
266-235-8
EC Name:
3,3'-methylenebis[5-methyloxazolidine]
Cas Number:
66204-44-2
Molecular formula:
C9H18N2O2
IUPAC Name:
3,3'-methylenebis[5-methyloxazolidine]
Details on test material:
- Name of test material (as cited in study report): Grotan OX
- Substance type: Formaldehyde releaser
- Physical state: Liquid
- Composition of test material, percentage of components: Reaction product from paraformaldehyde and 2 hydroxypropylamine (ratio of 3:2) )

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Copenhagen: Statens Serum Institute, Denmark. Stockholm: J.A. Sahlin, Malmö, Sweden
- Diet: ad libitum:
- Water: ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-22

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
other: petrolatum
Challenge
Route:
epicutaneous, semiocclusive
Vehicle:
other: petrolatum
No. of animals per dose:
20
Details on study design:
RANGE FINDING TESTS: Results are not presented but authors stated that moderate irritant concentrations for induction (intradermal and topical) and a non-irritant concentration for challenge were established.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: Day 0 (intradermal) and Day7 (dermal)
- Test groups: 3
- Control group: 1
- Site: back/flank
- Frequency of applications: 1 intradermal, 1 dermal
- Duration:
- Concentrations: 0.5% in water for intradermal injection and 10% in water for topical induction (causing moderate irritation)

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 21
- Exposure period: no data about exposure duration but presumably 24 h as suggested in Magnuson & Kligman (1970)
- Test groups: 1
- Control group: 1
- Site: back
- Concentrations: 0.1, 0.5 and 1%
- Evaluation (hr after challenge): 48

OTHER:
Positive control substance(s):
yes
Remarks:
Concurrently also other formaldehyde releasers were tested which gave positive results

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
1.0%
No. with + reactions:
12
Total no. in group:
20
Clinical observations:
mean response: grade 1.12 erythema
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1.0% . No with. + reactions: 12.0. Total no. in groups: 20.0. Clinical observations: mean response: grade 1.12 erythema.
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.5%
No. with + reactions:
7
Total no. in group:
20
Clinical observations:
mean response: grade 1.12 erythema
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.5%. No with. + reactions: 7.0. Total no. in groups: 20.0. Clinical observations: mean response: grade 1.12 erythema.
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.1%
No. with + reactions:
2
Total no. in group:
20
Clinical observations:
mean response: grade 1.12 erythema
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.1%. No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: mean response: grade 1.12 erythema.
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
19
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 19.0. Clinical observations: none.

Applicant's summary and conclusion

Interpretation of results:
Category 1A (indication of significant skin sensitising potential) based on GHS criteria
Conclusions:
Strong sensitizer
Executive summary:

The assay is comparable to OECD guideline 406 with some restrictions concerning documentation. No readings after 24 h but clearly positive results after 48 h.
Guinea pig maximisation test (GPMT); 20 animals per group;
induction: 0.5% in water for intradermal injection and 10% in water for topical application (causing moderate irritation); challenge: 0.1, 0.5 or 1% in petrolatum (no irritation).

Sensitising effects in 60% of test animals at a 1.0% concentration. Test item is a strong sensitizer.