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Diss Factsheets

Administrative data

Description of key information

Absence of any local irritation reaction after application on the skin of the Chimexane CL.

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:
17 October to 10 November, 1995
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
GLP study conducted in compliance with OECD Guideline No. 406 with deviations: details of environmental conditions not reported
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
details of environmental conditions not reported
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Existing study have been conducted before adoption of the OECD TG 429 (LLNA).
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL- Source and lot/batch No.of test material: Chimex / M 303- Physical state: Yellowish limpid liquid- Date received: October 9, 1995- Purity test date: July 27, 1995STORAGE CONDITIONS OF TEST MATERIAL- Storage condition of test material: Stored at room temperature, away from the light and heat
Species:
guinea pig
Strain:
Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS- Source: BERTHO (22120 YFFINIAC, France).- Weight at study initiation: 251-401 g- Housing: Animals were housed individually in polypropylene cage (310 x 465 x 190).- Diet: Complete pelleted diet UAR 106 (91360 - Epinay sur Orge, France), ad libitum- Acclimation period: 5 daysIN-LIFE DATES: 17 October to 10 November, 1995
Route:
intradermal and epicutaneous
Vehicle:
water
Remarks:
distilled water
Concentration / amount:
intradermal: 20 % in distilled waterepicutaneous: undiluted test substance
Day(s)/duration:
9 days (Days 1 - 7 intradermal; Day 7-9)
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
water
Remarks:
distilled water
Concentration / amount:
3 % and 1 % in distilled water
Day(s)/duration:
Day 21-23
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
Test substance group: 10 animalsControl group: 5 animals
Details on study design:
RANGE FINDING TESTS: DETERMINATION OF THE MAXIMAL NON-IRRITANT CONCENTRATION FOR THE SKIN (MNIC):Three guinea-pigs were clipped at the dorsal level over a surface area of approximately 60 cm2. They receive on both sides of the spinal column, on the clipped area 3 symmetrical intradermal injections of 0.1 mL of the following preparations: Freund's Complete Adjuvant (FCA) diluted to 50% in distilled water; distilled water; a 50/50 mixture of the 2 solutions.7 days later, the animals were clipped again and test substance (0.2 mL of the test substance diluted to 10%, 5% and 1 % in distilled water) was applied for 24 hours under an occlusive patch. The cutaneous irritation reactions were assessed 24 and 48 h after removal of patches. The concentration retained for the challenge-test was the maximal concentration that produces no primary cutaneous irritation in the animals. MAIN STUDY A. INDUCTION EXPOSURE - No. of exposures: One- Test groups: Intradermally injected with 3 injections (0.1 mL each) Injection 1: Mixture 1:1 (v/v) of FCA and distilled water; Injection 2: the test material diluted to 20 % in distilled water; Injection 3: test material diluted to 20% in a mixture 1:1 (v/v) of FCA and distilled water.- Control group: Intradermally injected with 3 injections (0.1 mL each) Injection 1: Mixture 1:1 (v/v) of Freund's Complete Adjuvant and distilled water; Injection 2: vehicle distilled water (MERAM Batch 43211); Injection 3: 50 % of vehicle (w/v) in a mixture 1:1 (v/v) of FCA and distilled water.- Site: On both sides of the spinal column, at the scapular levelAs the material produces a local irritation after 7 days rest period, the 15 guinea-pigs (groups 1 and 2) were reclipped at the injection sites. B. INDUCTION EXPOSURE: TOPICAL- No. of exposures: One- Exposure period: 48 h- Test groups: 0.5 mL of the product as such was applied to the filter paper patch of 8 cm2 (2x4 cm) and kept in contact with the skin for 48 h with an occlusive patch.- Control group: 0.5 mL of the vehicle (distilled water) was applied to the filter paper patch of 8 cm2 (2x4 cm) and kept in contact with the skin for 48 h with an occlusive patch.- Site: Same intradermally injected area - Frequency of applications: Single applicationAfter a 11-day rest period, the guinea-pigs from both groups were clipped one last time at the dorso-lumbar region, the skin surface chosen corresponding to a zone which had not previously been in contact with the product tested.B. CHALLENGE EXPOSURE - No. of exposures: One - Day(s) of challenge: Day 21 - Exposure period: 24 h - Test groups: Test substance was applied under an occlusive patch, on the skin of each of the guinea-pigs from groups 1 and 2, two (2 x 2 cm) pieces of filter paper moistened with 0.2 mL of the product tested to its maximal non-irritant concentration (MNIC) and to a lower concentration. - Concentrations: 3 % and 1 % in distilled water - Evaluation: 24 and 48 h after patch removal OTHER:All the animals were weighed after the 2nd reading (48 hours after patch removal - challenge test).
Positive control substance(s):
yes
Remarks:
2-Mercapto Benzothiazole
Positive control results:
The validity of the method and animals strain reactivity were confirmed by the study EVIC-CEBA Tb 282, May 23, 1995. The product 2-Mercapto Benzothiazole (positive control) appears highly sensitizing for the guinea-pig (class 4: 70 % of reactive animals) when it is used diluted to 5 % and 2 % in liquid petrolatum.
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
3% diluted product in distilled water
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
3% diluted product in distilled water
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
3% diluted product in distilled water
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
3% diluted product in distilled water
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
1% diluted product in distilled water
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
1% diluted product in distilled water
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
1% diluted product in distilled water
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
1% diluted product in distilled water
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation

Determination of the MNIC

The product diluted to 3 and 1 % in distilled water was retained for the challenge test. The 5% dilution which produces very slight irritation reactions was not retained.

 

Determination of the sensitizing potential

Guinea-pigs from group 1 after application of the test substance diluted to 3 and 1% in distilled water (indicator of cutaneous tolerance) showed no local irritation reactions after 24 and 48 h after patch removal.

 

Guinea-pigs from group 2 (previously sensitized by intradermal and epicutaneous routes on another site of the skin), the absence of any local irritation reaction after application on the skin of the test substance diluted to 3 and 1 % in distilled water, in the same conditions as for animals from group 1. The percentage of reactive animals is equal to 0 %.

 

General state - Mortality

The general state of health of all guinea-pigs put in experimentation remained satisfactory throughout the test.

The weight growth of all the animals was satisfactory. The mean weight gain calculated for the treated animals during the test period is not significantly different of that of the control animals.

Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions, the test substance is not sensitizing by contact with the skin according to the Regulation (EC) N° 1272-2008 (CLP) and GHS.
Executive summary:

In a Magnusson & Kligman maximisation study (GPMT) performed according to OECD Guideline 406 and in compliance with GLP, 10 female Hartley guinea pigs were induced with three pairs of intradermal injections (0.1 mL each) of FCA and distilled water in the ratio 1:1 (v/v); a 20 % formulation of the test material in distilled water; a 20% formulation of the test substance in a mixture 1:1 (v/v) of FCA and distilled water, on Day 1 on both sides of the spinal column, at the scapular level. Whereas, control group of 5 females was intradermally induced with 0.1 mL of FCA and distilled water in the ratio 1:1 (v/v); vehicle (distilled water); 50 % of vehicle (w/v) in a mixture 1:1 (v/v) of FCA and distilled water. As the substance produces a local irritation after 7 days rest period, the 15 guinea-pigs (groups 1 and 2) were re-clipped at the injection sites. On Day 8, 0.5 mL of the product as such was applied via occluded filter paper patch for 48 h in test group, whereas control group was applied with vehicle alone. On Day 21, a challenge filter paper patch loaded with test substance (3 % and 1 % in distilled water) was applied on the skin.

In the control group, no local irritation reactions were observed after 24 and 48 h after patch removal. In the treated group, the absence of any local irritation reaction after application on the skin of the test substance diluted to 3 and 1 % in distilled water, in the same conditions as for animals from group 1. The percentage of reactive animals is equal to 0 %.

 

The sensitivity and validity of the experiment was confirmed with known sensitiser, 2-Mercapto benzothiazole.

 

Under the test conditions, the test substance is not sensitizing by contact with the skin according to the Regulation (EC) N° 1272-2008 (CLP) and GHS.

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

In a GLP skin sensitization test in guinea pigs, conducted according to OECD guideline 406, 0 out of 10 animals in Chimexane CL treated group had positive reactions at both 24 and 48h readings.

Justification for selection of skin sensitisation endpoint:

only one study available for this endpoint.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

As 0% of tested animals had positive response in a maximisation test, it is concluded that Chimexane CL does not need to be classified as skin sensitiser according to the CLP Regulation (EC) N° (1272 -2008).