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Diss Factsheets

Administrative data

Description of key information

Not skin sensitising

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From September 26th to December 1th, 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
A LLNA study has not been conducted because adequate data from guinea pig Maximisation test study are already available.
Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS- Source: CIBA-GEIGY Limited- Weight at study initiation: 301-421 g- Housing: individually in Macrolon cages (type 3) randomly- Diet (e.g. ad libitum): ad libitum standard guinea pig pellets -NAFAG No. 845, Gossau SG All batches of the diet are assayed for nutritive ingredients and contamination level by the manufacturer.- Water (e.g. ad libitum): fresh waterThe drinking water quality fulfilled the critical parameters in the specifications of the "Schweizerisches Lebensmittelbuch" (Edition 1972).- Acclimation period: from 21th of September 1994- Sensitivity of the strain: checked once or twice a year with a known mild to moderate sensitiser, such as mercaptobsnzothiazole, hexyl cinnamic aldehyde or potassiumdichromate.ENVIRONMENTAL CONDITIONS- Temperature (°C): 22 ± 3°C- Humidity (%): 30 to 70%- Photoperiod (hrs dark / hrs light): 12 hours light cycle day.
Route:
other: intradermal injection and epidermal application
Vehicle:
physiological saline
Concentration / amount:
INTRADERMAL INJECTION: 5% in physiological saline (w/v).EPIDERMAL APPLICATION: 30 and 50% in physiological saline
Route:
epicutaneous, occlusive
Vehicle:
physiological saline
Concentration / amount:
INTRADERMAL INJECTION: 5% in physiological saline (w/v).EPIDERMAL APPLICATION: 30 and 50% in physiological saline
No. of animals per dose:
INTRADERMAL APPLICATION Three pairs of intradermal injections (0.1 ml per injection):- adjuvant/saline mixture 1:1 (v/v)- 5% FAT 21070/B in physiological saline (w/v)- 5% FAT 21070/B in the adjuvant/saline mixture (w/v)EPIDERMAL APPLICATIONThe application site of all animals was pretreated with 10% sodium-laurylsulfate (open application)- 50% FAT 21070/B in physiological salineCHALLENGE- 30% FAT 21070/B in physiological saline
Details on study design:
RANGE FINDING TESTS:The test started with the minimum number of animals (5 per sex for the test group and 5 of one sex for controls). After the challenge procedure, it wasnot possible to conclude if the test substance is a sensitiser or not and therefore testing in additional animals was performed to give a total of 20 test and 10 controlanimals.MAIN STUDYA. INDUCTION EXPOSURE: INTRADERMAL INJECTION- No. of exposures: 3 pairs- Control group: adjuvant/saline mixture and physiological saline- Site: left and right side of the shaved neck- Frequency of applications: three simultaneouslyA. INDUCTION EXPOSURE: EPIDERMAL APPLICATION- No. of exposures: 6 animalsThe application site of all animals was pretreated with 10% sodium-laurylsulfate (open application)- Type of application: on a filterpaper patch patch 2x4 cm; 0,4 g per patch; occluded administration;- Site: the neck of the animals- Duration: 48 h- Control group: a physiological saline onlyB. CHALLENGE EXPOSURE- No. of exposures: 6 animals- Type of application: flank in physiological saline; 2x2 cm patch; 0.2 g per patch- Site: the neck of the animals- Duration: 24 h- Control group: a physiological saline only
Positive control results:
Number of positive animals per group after occlusive epidermal application : 0 (24 and 48 hours)
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
after occlusive epidermal application
No. with + reactions:
2
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: after occlusive epidermal application. No with. + reactions: 2.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
after occlusive epidermal application
No. with + reactions:
3
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: after occlusive epidermal application. No with. + reactions: 3.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
other: control group- vehicle control
Dose level:
epidermal application-removal of dressing
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
DRAIZE score= erythema; edema
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: other: control group- vehicle control. Dose level: epidermal application-removal of dressing. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: DRAIZE score= erythema; edema.
Reading:
1st reading
Hours after challenge:
24
Group:
other: control group- test article control
Dose level:
epidermal application-removal of dressing
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
DRAIZE score= erythema; edema
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: other: control group- test article control. Dose level: epidermal application-removal of dressing. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: DRAIZE score= erythema; edema.
Reading:
2nd reading
Hours after challenge:
48
Group:
other: control group-vehicle control
Dose level:
epidermal application-removal of dressing
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
DRAIZE score= erythema; edema
Remarks on result:
other: see Remark
Remarks:
Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: control group-vehicle control. Dose level: epidermal application-removal of dressing. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: DRAIZE score= erythema; edema.
Reading:
2nd reading
Hours after challenge:
48
Group:
other: control group- test article control
Dose level:
epidermal application-removal of dressing
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
DRAIZE score= erythema; edema
Remarks on result:
other: see Remark
Remarks:
Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: control group- test article control. Dose level: epidermal application-removal of dressing. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: DRAIZE score= erythema; edema.
Reading:
1st reading
Hours after challenge:
24
Group:
other: test group-vehicle control
Dose level:
epidermal application-removal of dressing
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
DRAIZE score=erythema; edema
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: other: test group-vehicle control. Dose level: epidermal application-removal of dressing. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: DRAIZE score=erythema; edema.
Reading:
1st reading
Hours after challenge:
24
Group:
other: test group- vehicle control
Dose level:
epidermal application-removal of the dressing
No. with + reactions:
4
Total no. in group:
20
Clinical observations:
DRAIZE score=erythema; edema
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: other: test group- vehicle control. Dose level: epidermal application-removal of the dressing. No with. + reactions: 4.0. Total no. in groups: 20.0. Clinical observations: DRAIZE score=erythema; edema.
Reading:
2nd reading
Hours after challenge:
48
Group:
other: test group-vehicle control
Dose level:
epidermal application-removal of the dressing
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
DRAIZE score=erythema; edema
Remarks on result:
other: see Remark
Remarks:
Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: test group-vehicle control. Dose level: epidermal application-removal of the dressing. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: DRAIZE score=erythema; edema.
Reading:
2nd reading
Hours after challenge:
48
Group:
other: test group-test article
Dose level:
epidermal application-removal of the dressing
No. with + reactions:
4
Total no. in group:
20
Clinical observations:
DRAIZE score=erythema; edema
Remarks on result:
other: see Remark
Remarks:
Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: test group-test article. Dose level: epidermal application-removal of the dressing. No with. + reactions: 4.0. Total no. in groups: 20.0. Clinical observations: DRAIZE score=erythema; edema.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
30% intradermal injections of an adjuvant/saline mixture 1:1 (v/v; 0.1 ml per injection)
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
erithema, edema
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 30% intradermal injections of an adjuvant/saline mixture 1:1 (v/v; 0.1 ml per injection). No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: erithema, edema.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50% intradermal injections of an adjuvant/saline mixture 1:1 (v/v; 0.1 ml per injection)
No. with + reactions:
2
Total no. in group:
20
Clinical observations:
erythema, edema
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50% intradermal injections of an adjuvant/saline mixture 1:1 (v/v; 0.1 ml per injection). No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: erythema, edema.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
30% intradermal injections of an adjuvant/saline mixture 1:1 (v/v; 0.1 ml per injection)
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
erythema;edema
Remarks on result:
other: see Remark
Remarks:
Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 30% intradermal injections of an adjuvant/saline mixture 1:1 (v/v; 0.1 ml per injection). No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: erythema;edema.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50% intradermal injections of an adjuvant/saline mixture 1:1 (v/v; 0.1 ml per injection)
No. with + reactions:
1
Total no. in group:
20
Clinical observations:
edema
Remarks on result:
other: see Remark
Remarks:
Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50% intradermal injections of an adjuvant/saline mixture 1:1 (v/v; 0.1 ml per injection). No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: edema.
Group:
negative control
Remarks on result:
no indication of skin sensitisation
Group:
positive control
Remarks on result:
other: not reported

After removal of the dressing on day 10, irritation of the epidermal application site was observed in 10/10 control and in 20/20 test group animals.

Body weights were not affected by treatment.

Interpretation of results:
other: CLP criteria not met
Conclusions:
Not skin sensitising
Executive summary:

The determination of the sensitizing potential was determined by a Maximixation test, according to OECD 406 guideline and GLP. The reaction on the test substance was observed in Guinea Pigs for 48 hours. Induction reactions, challenge reactions and changes in body weight were observed.

Under the experimental conditions employed, 10% and 15% of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings, respectively. According to the maximisation grading of Magnusson and Kligman the substance showed a mild grade of skin-sensitising (contact allergenic) potential in albino guinea pigs. Body weights were not affected by treatment.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The determination of the sensitizing potential was determined by a Maximixation test, according to OECD 406 guideline and GLP. The reaction on the test substance was observed in Guinea Pigs for 48 hours. Induction reactions, challenge reactions and changes in body weight were observed. Under the experimental conditions employed, 10% and 15% of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings, respectively. According to the maximisation grading of Magnusson and Kligman the substance showed a mild grade of skin-sensitising (contact allergenic) potential in albino guinea pigs. Body weights were not affected by treatment.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

No data available


Justification for classification or non-classification

Skin sensitisation

According to the guide to the labelling of dangerous substances and the criteria for the choice of sentences indicating particular hazards (R sentences) attributed to dangerous substances (Commission Directive 93/21/EEC, April 27, 1993) a test article was classified as a sensitizer in the case where a positive response was noted in at least 30 % of the animals.

Under the experimental conditions employed, 10% and 15% of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings, respectively, therefore it cannot be classified a sensitizer (contact allergenic) potential in albino guinea pigs.

However, according to the CLP Regulation n. 1272/2008, a substances shall be classified as skin sensitisers (Category 1) where data are not sufficient for sub- categorisation (1A and 1B) in accordance with the following criteria:

(a) if there is evidence in humans that the substance can lead to sensitisation by skin contact in a substantial number of persons; or

(b) if there are positive results from an appropriate animal test ( according to 3.4.2.2.4.1).

At this point, when an adjuvant type guinea pig test method for skin sensitisation is used, a response of at least 30 % of the animals is considered as positive. For a non-adjuvant guinea pig test method a response of at least 15 % of the animals is considered positive.

The study reported was performed according to OECD 406, that includes the use of the adjuvant.

Positive results were observed, 10% and 15% of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings, respectively).

Based on these results, according to the paragraph 3.4. of the CLP Regulation n. 1272/2008, the substance shall be non classified as a skin sensitizer.

Respiratory sensitisation

No study available for this endpoint.