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Diss Factsheets

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1991-07-08 until 1991-08-08
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: OECD 406 guideline (adopted 1981) study, GLP compliance. It is unclear, if sodium lauryl sulfate treatment was done for this non-irritant test item.
Cross-reference
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
OECD Guideline No. 406, adopted May 12, 1981
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Version / remarks:
of April 25, 1984
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Details on test material:
- Purity: > 90%
- Physical properties: solid, red
- Storage conditions: room temperature
- Validity: March, 1996

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Pirbright White Strain (Tif: DHP)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: CIBA-GEIGY Limited Animal Production 4332 Stein / Switzerland
- Age at study initiation: 10 weeks old
- Weight at study initiation: 324 to 412 g
- Housing:
- Diet: ad libitum standard guinea pig pellets
- Water: ad libitum fresh water
- Acclimation period: 5 days

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

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
arachis oil
Concentration / amount:
Intradermal Induction: 5 % in arachidis oil
Epidermal applications (induction): 30 % in vaseline
Epidermal applications (challenge): 10 % in vaseline
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
arachis oil
Concentration / amount:
Intradermal Induction: 5 % in arachidis oil
Epidermal applications (induction): 30 % in vaseline
Epidermal applications (challenge): 10 % in vaseline
No. of animals per dose:
10 guinea pigs in the test group
5 guinea pigs in the control group
Details on study design:
RANGE FINDING TESTS:
- For intradermal induction (intradermal injection): Concentrations of test article tested: 1, 3, and 5 % in arachidis oil. Since 5 % of test item in arachidis oil could be injected and was well tolerated, this concentration was used for the intradermal induction.
- Epidermal Applications (induction and challenge): The following concentrations of the test item have been examined on separate animals for the determination of the maximum subirritant concentration: 1, 5, 10, and 30% in vaseline. The tested concentrations did not induce erythema reactions.
The following concentrations were used for epidermal induction: 30 % test item in vaseline.
The following concentrations were used for epidermal challenge: 10 % test item in vaseline. Because a higher concentration may lead to nonspecific reactions in adjuvant treated animals.

MAIN STUDY
A. INDUCTION EXPOSURE
- The induction was a two-stage operation. First, intradermal injections (into the neck region); second, closed patch exposure
over the injection sites one week later
- First induction week, intradermal injection
Three pairs of intradermal injections (0.1 ml per injection) were made simultaneously into the shaved neck of the guinea
pigs as follows:
- adjuvant/saline mixture 1:1 (v/v)
- test article in 01. arachidis (w/v)
- test article in the adjuvant saline mixture (w/v)
- Second induction week, epidermal application
In the second week of induction the test item was incorporated in vaseline (w/w) and applied on a filterpaper patch to the neck
of the animals (patch 2x4 cm; approx. 0.4 g paste per patch; occluded administration for 48 hours)
- Sodium lauryl sulfate (SLS) treatment: unclear; the study report mentions SLS only under "observations" (but not under "test procedure"): "... irritant reactions are normally induced by the adjuvant, the high test article concentration, or the sodium lauryl sulfate pretreatment".

- Rest period: During weeks 3 and 4 no treatments were performed

B. CHALLENGE EXPOSURE (week 5)
- The animals were tested on the flank with the test item in vaseline (w/w) and the vehicle alone (patch 2x2 cm; approx. 0.2 g paste per patch; occluded administration for 24 hours).
- Evaluation (hr after challenge): 24 and 48

C. CONTROL GROUP
A control group of 10 animals (5 m/5 f) was treated with adjuvant and the vehicle during the induction period. During the challenge period the group was treated with the vehicle as well as with the test article to check the maximum subirritant concentration of the test article in adjuvant treated animals.

Positive control substance(s):
yes
Remarks:
2,4-dinitrochlorobenzene

Results and discussion

Positive control results:
The sensitivity of the strain is checked every six months with a known sensitiser. In this assay 2,4-dinitrochlorobenzene revealed the expected results indicating the sensitivity and suitability of the test system.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10 % (challenge)
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: 10 % (challenge). No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10 % (challenge)
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: 10 % (challenge). No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
10 % (challenge)
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: 10 % (challenge). No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
10 % (challenge)
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: 10 % (challenge). No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.1 % 1-Chloro-2,4-dinitrobenzene (challenge)
No. with + reactions:
10
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.1 % 1-Chloro-2,4-dinitrobenzene (challenge). No with. + reactions: 10.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
0.1 % 1-Chloro-2,4-dinitrobenzene (challenge)
No. with + reactions:
10
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 0.1 % 1-Chloro-2,4-dinitrobenzene (challenge). No with. + reactions: 10.0. Total no. in groups: 10.0.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU