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Diss Factsheets

Administrative data

Description of key information

A guinea pig maximization test was performed and it was concluded that the test substance was non sensitising to the skin.

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:
1984-09-18 to 1984-10-18
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
No LLNA study was conducted as an in vivo study comparable to OCED 406 was conducted, before the first version of the LLNA (OECD 429) was issued in 2002.
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 5-8 weeks
- Weight at study initiation: 260-377 g
- Housing: up to 4/cage, solid-floor polypropylene cages (supplied by NKP Limited, Dartford, Kent)
- Diet: ad libitum, Guinea Pig FD1 Diet (supplied by Special Diet Services Limited, Witham, Essex)
- Water: ad libitum, tap water
- Acclimation period: min. 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.5 ± 2.5
- Humidity (%): 60-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Route:
intradermal and epicutaneous
Vehicle:
other: liquid paraffin for injection and petroleum jelly for topical application
Concentration / amount:
Intradermal Induction: 5 % in liquid paraffin
Topical Induction: 100 %
Route:
epicutaneous, occlusive
Vehicle:
other: petroleum jelly for topical application
Concentration / amount:
Topical Challenge: 100 %
Day(s)/duration:
24 h application
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
20
Details on study design:
RANGE FINDING TESTS (called Preliminary Siting test):
- Injection with 0.1 mL of 1 (1 animal) and 5 % (1 animal) test substance with observation after 24, 48 and 72 h and 7 days.
- Topical application: 2 cm* 2 cm patches with 50 and 100 % concentration were applied to clipped skin of guinea pigs (4 animals) that were injected with adjuvant 1-3 weeks before. Patches and left over test substance were removed after 24 h with washing. After 1, 24 and 48 h the skin was evaluated. The maximum non-irritant concentration of the test material was selected for the main study.


MAIN STUDY
A.1 INDUCTION EXPOSURE (Injection)
- No. of exposures: 1 (3 injection sides)
- Exposure period: 1 injection and 6 days observation
- Test group: 20 animals received 3 pairs of injections: (1) 0.1mL of Freunds complete adjuvant (Difco Laboratories, Detroit, Michigan USA) (2) 0.1mL of a 5 % concentration of the test material (3) 0.1mL of a 50:50 mixture of a 5 % concentration of the test material emulsified in the adjuvant
- Control group: 10 animals received 3 pairs of injections: (1) 0.1mL of Freunds complete adjuvant (2) 0.1mL of vehicle alone (3) 0.1mL of a 50:50 mixture of vehicle emulsified in Freunds complete adjuvant
- Site: 4 cm x 6 cm in the shoulder region
- Frequency of applications: 1 application
- Duration: single injection
- Concentrations: 5 % and 50:50 mixture of a 5 % concentration of the test material emulsified in the adjuvant

A.2 INDUCTION EXPOSURE (topical)
- No. of exposures: 1
- Day after intradermal injection: day 7
- Exposure period: 48 h
- Test groups: 100 % test substance on Whatman No 4 Filter paper, fixed with Sleek waterproof adhesive strapping in a cross and 3.5 cm x 25 cm length of Elastoplast elastic adhesive bandage which was wound in a double layer around the torso of the animal
- Control group: similar to test group but only vehicle
- Site: 2 cm x 4 cm in the shoulder region
- Concentrations: 100 %

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: 21
- Exposure period: 24 h
- Test group: on clipped right flank 100 %, on clipped left flank vehicle
- Control group: on clipped right flank 100 %, on clipped left flank vehicle
- Site: 5 cm x 5 cm an both flanks
- Concentrations: 100 %
- after 24 h the patches were removed and challenge sites were cleaned using cotton wool soaked in lukewarm water or ether
- Evaluation: was done 24 h after removal (48 h after application) and after 48 h (72 h)

OTHER:
on day 0 and day 24 body weights were recorded
Challenge controls:
yes, see above
Positive control substance(s):
no
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
GHS criteria not met
Conclusions:
A guinea pig maximization test was conducted. The challenge with 100 % of the test substance resulted in no reactions and therefore it was concluded that the test substance was non sensitising.
Executive summary:

A guinea pig maximization test was conducted. The test group consisted of 20 and the control group of 10 guinea pigs. Intradermal induction was done with 3 injection pairs into different sides. The injections contained 1) Freunds complete adjuvant, 2) 5 % concentration of the test material or vehicle only for the control group and 3) 50:50 mixture of a 5 % concentration of the test material emulsified in the adjuvant or 50:50 mixture of vehicle emulsified in Freunds complete adjuvant for the control animals. The topical induction was done with 100 % test substance or vehicle for the control group. The challenge with 100 % of the test substance resulted in no reactions in any of the 20 guinea pigs both at the 24 h and 48 h observations. The animals of the control group showed no reactions either. Therefore it was concluded that the test substance was non sensitising.

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

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

A guinea pig maximization test was conducted. The test group consisted of 20 and the control group of 10 guinea pigs. Intradermal induction was done with 3 injection pairs into different sides. The injections contained 1) Freunds complete adjuvant, 2) 5 % concentration of the test material or vehicle only for the control group and 3) 50:50 mixture of a 5 % concentration of the test material emulsified in the adjuvant or 50:50 mixture of vehicle emulsified in Freunds complete adjuvant for the control animals. The topical induction was done with 100 % test substance or vehicle for the control group. The challenge with 100 % of the test substance resulted in no reactions in any of the 20 guinea pigs both at the 24 h and 48 h observations. The animals of the control group showed no reactions either. Therefore it was concluded that the test substance was non sensitising.

A maximization test in 25 human volunteers was conducted (supporting study, see IUCLID section 7.10.4) to test the senstising potential of the test substance. The test substance was applied on the volar forearm or back with an occlusive dressing for 5 alternate-day 48 h periods. The patch sides were pretreated with 2.5 % aqueous sodium lauryl sulfate under occlusion. The challenge side was read immediatly after patch removal and after 24 h. No volunteer showed any reaction on the skin. The test substance was not contact sensitising in humans.

 

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data is reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on skin sensitisation, the test item is not classified according to Regulation (EC) No 1272/2008 (CLP), as amended for the ninth time in Regulation (EU) No 2016/1179.