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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with well documented report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
Study pre-dates the development of the LLNA test.

Test material

Constituent 1
Details on test material:
- Physical state: Powder
- Lot/batch No.: Mix 51785
- Stability under test conditions: Stable under storage conditions
- Storage condition of test material: At room temperature in the dark

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga, Sulzfeld/West Germany
- Age at study initiation: Approximately 11 weeks
- Weight at study initiation: 349-446 grams
- Housing: Group housing of 2 animals per cage with wire-mesh floors
- Diet (e.g. ad libitum): Free access to standard guinea pig diet, including ascorbic acid, LC 23-B, pellet diameter 4mm. Once weekley hay was provided.
- Water (e.g. ad libitum): Free access to tap -water, diluted with decalcified water.
- Acclimation period: At least five days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/-3C
- Humidity (%): 30-70%
- Air changes (per hr): 7.5-15
- Photoperiod (hrs dark / hrs light): 12 hours artifical fluorescent light/ 12 hours dark


IN-LIFE DATES: From: May 8, 1989 To: June 6, 1989

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: 1% methyl cellulose
Route:
epicutaneous, occlusive
Vehicle:
other: methylcellulose
Concentration / amount:
Concentration of test material and vehicle used at induction: 50% (w/w) with 1% methylcellulose.
Nine topical applications were made, each of 6 hours duration, over a period of 3 weeks.

Concentration of test material and vehicle used for each challenge: 50% (w/w) in 1% methlcellulose, topically.
Challengeopen allclose all
Route:
epicutaneous, semiocclusive
Vehicle:
other: 1% methyl cellulose
Concentration / amount:
Concentration of test material and vehicle used at induction: 50% (w/w) with 1% methlcellulose.
Nine topical applications were made, each of 6 hours duration, over a period of 3 weeks.

Concentration of test material and vehicle used for each challenge: 50% (w/w) in 1% methlcellulose, topically.
No. of animals per dose:
Number of animals in test group: 20
Number of animals in negative control group: 10
Details on study design:
RANGE FINDING TESTS:

Primary Irritaion
One animal treated with 50% (w/w) concetration of test material in 1% methyl cellulose for 24 hours and assessed for erythema at 24 and 48 hours.
Four animals treated with 50%, 25%, 10%, and 5% (w/w) concetration of the test material in 1% methyl cellulose for 6 hours and assessed for erythema at 24 and 48 hours.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: nine
- Exposure period: 6 hours
- Test groups: test material 50% (w/w) with 1% methyl cellulose
- Control group: 1% methyl cellulose
- Frequency of applications: Days 1, 3, 5, 8, 10, 12, 15, 17, and 19
- Duration: 6 hours
- Concentrations: same throughout


B. CHALLENGE EXPOSURE
- No. of exposures: One
- Day(s) of challenge: Day 29
- Exposure period: 6 hours
- Test groups: test article 50% in 1% methyl cellulose
- Control group: test article 50% in 1% methyl cellulose and 0.5ml of 1% methyl cellulose
- Evaluation (hr after challenge): 24 and 48 hours

Challenge controls:
Control animals were challenged to 0.5ml of the test article: 50% (w/w) in 1% methyl cellulose and to 0.5 ml of 1% methyl cellulose.
Positive control substance(s):
yes
Remarks:
Formaldehyde

Results and discussion

Positive control results:
Formaldehyde was used as the positive control;
Concentrations selected for the study were
Induction- 0.5% (w/w) in milli-R0 water
Challenge- 0.5%, 0.25%, 0.1% (w/w) in milli-R0 water and milli-R0 water

Clearly positive results were observed in the experimental animals with a senstization rate of 68%, 63, %, 5%, and 0% for 0.5%, 0.25%, 0.1% and 0% respectively.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.5 %
No. with + reactions:
13
Total no. in group:
20
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.25 %
No. with + reactions:
12
Total no. in group:
20
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.1 %
No. with + reactions:
1
Remarks on result:
no indication of skin sensitisation

Any other information on results incl. tables

There were no signs of irritation noted in the primary irritation experiments therfore Induction was set at 50% (w/w) in 1% methyl cellulose. There were no signs of irritation observed at the end of the induction phase and no
evidence of sensitisation of any challenge concentration.
Other observations:
No signs of toxicity or effects on body weight were observed.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information not classified
Conclusions:
The test material resulted in a zero percent sensitization in the guinea pig. The test material is not classifed under EEC Council Directive 67/548/EEC (amended by Directive 83/467/EEC) or by EC 1272/2008.
Executive summary:

Under the conditions of the study, the t4est material lead to a sensitzation rate of 0 percent and is not classifed under EEC Council Directive 67/548/EEC (amended by Directive 83/467/EEC) or by EC 1272/2008.