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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Description of key information

In a study according OECD TG 406 performed on guinea-pigs the substance is not to be classified as skin sensitizer (reference 7.4.1 -1).

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
07-1992
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Version / remarks:
not further specified
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Study performed in 1995
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: David Hall Ltd., Burton-on-Trent, UK
- Age at study initiation: 8 – 12 weeks
- Weight at study initiation: 360 – 427 g
- Housing: singly or in pairs in solid-floor PP cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 – 23
- Humidity (%): 48 – 68
- Photoperiod (hrs dark / hrs light): 12 hour light - 12 hour dark regime
Route:
intradermal
Vehicle:
arachis oil
Concentration / amount:
0.1 mL of 25 % (w/v) in arachis oil B.P., 25 % (w/v) in a mixture of Freund's Complete Adjuvant plus distilled water (1:1)
Day(s)/duration:
day 0
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
Filter patch saturated with the undiluted test material
Day(s)/duration:
Application on day 7 over 48 hours
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
arachis oil
Concentration / amount:
Filter patch saturated with the undiluted test material (100 and 75% (v/v))
Day(s)/duration:
day 21 over 24 hours
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
Number of animals in test group: 10
Number of animals in negative control group: 5
Details on study design:
RANGE FINDING TESTS: The concentrations for the main study were determined by 'sighting tests' in which groups of guinea pigs were treated with various concentrations of test material.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and topical)
- Test groups:
a) Freund's Complete Adjuvant plus distilled water in the ratio 1:1
b) a 25% w/v formulation of the test material in arachis oil B.P.
c) a 25% w/v formulation of the test material in a 1:1 preparation of Freund's Complete Adjuvant plus distilled water.

One week later (Day 7), the same area on the shoulder region used previously for intradermal injections was clipped again and treated with a topical application of the undiluted test material. A filter paper patch saturated with the undiluted test material was applied to the prepared skin and held in place with a strip of surgical adhesive tape covered with an overlapping length of aluminium foil. This occlusive dressing was kept in place for 48 hours.

- Control group:
a) Freund's Complete Adjuvant plus distilled water in the ratio 1:1
b) arachis oil B.P.
c) 50% w/v formulation of arachis oil B.P. in a 1:1 mixture of Freund's Complete Adjuvant/distilled water

The topical applications followed the same procedure as for the test animals except that nothing was applied to the filter paper. Skin reactions were quantified as for the test animals.

B. CHALLENGE EXPOSURE
- No. of exposures: 1 (topical)
- Day(s) of challenge: 21
- Exposure period: 24 h
- Test groups:
A square filter paper patch, saturated with the undiluted test material was applied to the shorn right flank of each animal and was held in place with a strip of surgical adhesive tape. To ensure that the maximum non-irritant concentration was used at challenge, the test material at a concentration of 75% v/v in arachis oil B.P. was similarly applied to a skin site on the left shorn flank. The patches were occluded with an overlapping length of aluminium foil and secured with a strip of elastic adhesive bandage wound in a double layer around the torso of each animal.

After 24 hours, the dressing was carefully cut using blunt-tipped scissors, removed and discarded. The challenge sites were swabbed with cotton wool soaked in diethyl ether to remove residual material. The position of the treatment sites was identified by using a black indelible marker-pen. Prior to the 24-hour observation the flanks were clipped using veterinary clippers to remove regrown hair.
Challenge controls:
yes
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:
10
Clinical observations:
no
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:
10
Clinical observations:
no
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
75 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
75 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
75 %
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
75 %
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Group:
positive control
No. with + reactions:
7
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation

Bodyweight

Bodyweight gains-of guinea pigs in the test group, between Day 0 and Day 24, were comparable to those observed in the control group animals over the same period.

Positive control

SUMMARY OF POSITIVE CONTROL DATA FOR THE MAGNUSSON AND KLIGMAN MAXIMISATION STUDY (NOVEMBER 1993 TO NOVEMBER 1994)

Project
Number

Date Start

Date
End

Number of Animals
and Sex*

Positive Control Material

concentration
Induction

Challenge

Incidence of
Sensitisation

 

 

 

 

 

 

Test

Control

 

 

Intradermal

Topical

 

 

 

 

039/62

19/10/93

12/11/93

10

Female

5

Female

alpha-hexylcinnamaldehyde Tech.
85%

25% in arachis
oil B.P.

100%

100% and
75% in
arachis oil
B.P.

70% (7/10)

039/70

01/03/94

25/03/94

10
female

5

Female

2-Mercaptobenzothiazole

10% in arachis
oil B.P.

50% in 95%
aqueous
ethanol

25% in 95%
aqueous
ethanol

80% (8/10)

039/85

13/07/94

06/08/94

18
Female

10

Female

Ethyl 4 aminobenzoate 98%

3% in a 6%
preparation of

acetone in
arachis oil B.P.

25% in 80%
aqueous
ethanol

10% and 5%
in 80%
aqueous
ethanol

39% (7/18)

039/108

31/10/94

24/11/94

9
Male

5
Male

2,4-Dinilrochlorobenzene

0.1 % in arachis
oil B.P.

1 % in arachis
oil B.P.

0.1% and
0.05% in
arachis oil
B.P.

100% (9/9)

 

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the results of this study the test item can be assessed as a non sensitiser to guinea pig skin.
Executive summary:

The purpose of this GLP study performed according to OECD TG 406 was to assess the contact sensitisation potential of the test material in the albino guinea pig. Based on the results of sighting tests, the concentrations of test material for the induction and challenge phases were selected as follows:

Intradermal induction: 25 % (w/v) in arachis oil B.P.

Topical induction: undiluted as supplied

Topical challenge: 100 and 75% (v/v) in arachis oil B.P.

Skin reactions after intradermal induction: Well-defined to moderate to severe erythema was noted at all induction sites at the 24 and 48-hour observations in the test group animals. Very slight erythema was noted at all treatment sites at the 24-hour observation and one treatment site at the 48-hour observation in the control group animals.

Skin reactions after topical induction: Very slight erythema was noted at eight induction sites at the 1-hour observation with no dermal reactions at the 24-hour observation in the test group animals. No dermal reactions were noted at the 1 or 24-hour observations at the treatment sites of the control group animals.

Skin reactions after topical challenge: No skin reactions were noted at the challenge sites of the test or control group animals at the 24 or 48-hour observations at the 100% or 75% concentrations.

Bodyweight gains of guinea pigs in the test group, between days 0 – 24, were comparable to those observed in the control group animals over the same period.

The test item produced a 0 % (0/10) sensitisation rate in guinea pigs.

Based on the results of this study the test item can be assessed as a non sensitiser to guinea pig skin.

Endpoint:
skin sensitisation: in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

A study according to OECD TG 406 was performed to assess the contact sensitisation potential of the test material in the albino guinea pig. Based on the results of sighting tests, the concentrations of test material for the induction and challenge phases were selected as follows:

Intradermal induction: 25 % (w/v) in arachis oil B.P.

Topical induction: undiluted as supplied

Topical challenge: 100 and 75% (v/v) in arachis oil B.P.

Skin reactions after intradermal induction: Well-defined to moderate to severe erythema was noted at all induction sites at the 24 and 48-hour observations in the test group animals. Very slight erythema was noted at all treatment sites at the 24-hour observation and one treatment site at the 48-hour observation in the control group animals.

Skin reactions after topical induction: Very slight erythema was noted at eight induction sites at the 1-hour observation with no dermal reactions at the 24-hour observation in the test group animals. No dermal reactions were noted at the 1 or 24-hour observations at the treatment sites of the control group animals.

Skin reactions after topical challenge: No skin reactions were noted at the challenge sites of the test or control group animals at the 24 or 48-hour observations at the 100% or 75% concentrations.

Bodyweight gains of guinea pigs in the test group, between days 0 – 24, were comparable to those observed in the control group animals over the same period.

The test item produced a 0 % (0/10) sensitisation rate in guinea pigs.

Based on the results of this study the test item can be assessed as a non sensitiser to guinea pig skin (reference 7.4.1 -1).

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

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

The available test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on this information, the substance is not considered to be classified for skin sensitisation under Regulation (EC) No 1272/2008, as amended for the twelfth time in Regulation (EU) 2019/521.