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Diss Factsheets

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Adequacy of study:
other information

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
Maurer optimisation test

Test material

Constituent 1
Chemical structure
Reference substance name:
N-[[(4-methylphenyl)sulfonyl]methyl]formamide
EC Number:
700-490-2
Cas Number:
36635-56-0
Molecular formula:
C9H11NO3S
IUPAC Name:
N-[[(4-methylphenyl)sulfonyl]methyl]formamide
Details on test material:
- Name of test material (as cited in study report):
- Physical state: solid
- Analytical purity: approx 100%
- Lot/batch No.: P. 709027

In vivo test system

Test animals

Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: approx 3 weeks

TEST ANIMALS
- Initial body weight range: 310 - 422g
- Age at study initiation: approx 3 weeks
- Housing: Macrolon cages type 3, std soft wood bedding
- Diet (e.g. ad libitum): NAFAG 846 Gossau SG, ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ±3°C
- Humidity (%): 30 - 70%
- Photoperiod (hrs dark / hrs light): 12hour/day light cycle

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
other: saline
Concentration / amount:
0.1% material in physiological saline
Challengeopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: saline
Concentration / amount:
0.1% material in physiological saline
No. of animals per dose:
20 (10m/10f)
Details on study design:
RANGE FINDING TESTS:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10
- Exposure period: 3 weeks
- Test groups: 2 groups of 10 males and 10 females
- Control group: 1 group of 10 males and 10 females
- Site: right flank and back
- Frequency of applications: every second day (excluding weekends)
- Concentrations: 0.1% solution in physiological saline

B. CHALLENGE EXPOSURE - INTRACUTANEOUS
- No. of exposures: 1
- Day(s) of challenge: 14 days post last sensitisation injection
- Exposure period: one dose
- Test groups: 2 groups of 10 males and 10 females
- Control group: 1 group of 10 males and 10 females - vehicle alone
- Site: left flank
- Concentrations: 0.1% solution in physiological saline

C. CHALLENGE EXPOSURE - EPICUTANEOUS
- No. of exposures: 1
- Day(s) of challenge: ten days post last sensitisation injection
- Exposure period: 24hrs
- Test groups: 2 groups of 10 males and 10 females
- Control group: 1 group of 10 males and 10 females - vasiline alone
- Site: occlusive dressing in place for 24hrs
Challenge controls:
Intradermal - vehicle alone
Epidermal - vasiline alone
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.1% intradermal injection
No. with + reactions:
20
Total no. in group:
20
Clinical observations:
Intradermal application provoked positive response in a significant number of animals
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1% intradermal injection. No with. + reactions: 20.0. Total no. in groups: 20.0. Clinical observations: Intradermal application provoked positive response in a significant number of animals.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10% epidermal application
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no difference between test group and control
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10% epidermal application. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no difference between test group and control.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10% epidermal application
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no difference between test group and control
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10% epidermal application. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no difference between test group and control.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
It can be concluded from the results that CGA 224433 tech does not provoke contact dermatitis after exposure on intact skin of artificially sensitised guinea pigs.
Executive summary:

A significant number of positive animals were observed in the test group compared to the vehicle treated control group only after intradermal application of CGA 224433 tech.

The negative results upon epidermal challenge application demonstrate that, in artificially sensitised guinea pigs, exposure to CGA 224433 tech. on intact skin does not provoke contact dermatitis.