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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Skin sensitisation (OECD 406): not 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:
17 Oct - 22 Nov 1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
no SDS pretreatment although undiluted test substance caused no skin reactions; no reliability check (positive control); no data on analytical purity of test substance given.
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
adopted 12 May 1981
Deviations:
yes
Remarks:
no SDS pretreatment although undiluted test substance caused no skin reactions; no reliability check (positive control); no data on analytical purity of test substance given.
GLP compliance:
yes (incl. QA statement)
Remarks:
THE DEPARTMENT OF HEALTH AND SOCIAL SECURITY OF THE GOVERNMENT OF THE UNITED KINGDOM, UK
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The test was done before LLNA as first-choice method for in-vivo testing was set into force.
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Females nulliparous and non-pregnant: not specified
- Weight at study initiation: 430 - 533 g
- Housing: in groups of 10 in stainless steel cages
- Diet: antibiotic free guinea pig diet SQC, FD1 (Special Diets Services, Witham, England), ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: preliminary study: 5 days; main study: 18 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 24 (On 3 occasions only, the recorded temperature was 1°C below the protocol specified range.)
- Humidity (%): 34 - 65 (On several occasions the recorded relative humidity fell below the range specified in the protocol, the reading of 34% being recorded on 2 occasions only. These deviations are considered not to have affected the outcome of the study.)
- Photoperiod (hrs dark / hrs light): 12 / 12
Route:
intradermal
Vehicle:
arachis oil
Concentration / amount:
5% (v/v)
Day(s)/duration:
on Day 0; single injection
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:
100%
Day(s)/duration:
on Day 7; 48 h
Adequacy of induction:
other: non-irritant test substance
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: ethanol/diethylphthalate 1:1 (w/w) and unchanged (no vehicle)
Concentration / amount:
100% and 50% (v/v)
Day(s)/duration:
on Day 21; 24 h
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
20
Details on study design:
RANGE FINDING TESTS:
For the intradermal induction 0.1 mL of the test substance at concentrations of 0.5, 1, 2, 3, 4 and 5% in arachis oil BP were injected intradermally into the flanks of one animal. The highest concentration (5%) induced mild to moderate skin irritation and was selected for the main study. For the epicutaneous induction 4 animals (intradermally pretreated with FCA) were treated with the undiluted test substance and concentrations of 12.5, 25 and 50% (v/v) in ethanol/diethylphthalate 1:1 (w/w). Applications were made to the clipped flanks under occlusive dressings for 24 hours. Undiluted test article was found to be non irritant when applied topically and was therefore selected for the topical induction phase of the main study. Undiluted test substance and the 50% (v/v) concentration of the test substance were selected for the challenge of the main study.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous)
- Exposure period: single injection (intradermal) and 48 h (epicutaneous)
- Test groups:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture (v/v) FCA/water
Injection 2: 5% test substance in arachis oil
Injection 3: 5% (v/v) formulation of test substance in 1:1 preparation of FCA/water
Epicutaneous: test substance undiluted
- Control group:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture (v/v) FCA/water
Injection 2: arachis oil
Injection 3: 5% formulation of arachis oil in 1:1 preparation of FCA/water
Epicutaneous: ethanol/diethylphthalate 1:1 (w/w)
- Site: shoulder region (intradermal + epicutaneous)
- Frequency of applications: once
- Duration: Days 0 - 7
- Concentrations: intradermal 5%, epicutaneous 100%

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: 21
- Exposure period: 24 h
- Test groups: test substance and vehicle
- Control group: test substance and vehicle
- Site: left flank (undiluted test substance) and right flank (50% test substance)
- Concentrations: 50% (v/v) and 100%
- Evaluation: 24 and 48 h after challenge patch removal
Challenge controls:
The control group is actually a challenge control.
Positive control substance(s):
no
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
Challenge: 50%
No. with + reactions:
0
Total no. in group:
20
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
Challenge: 100%
No. with + reactions:
0
Total no. in group:
20
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
Challenge: 50%
No. with + reactions:
0
Total no. in group:
20
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
Challenge: 100%
No. with + reactions:
0
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
Challenge: 50%
No. with + reactions:
0
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
Challenge: 100%
No. with + reactions:
0
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
Challenge: 50%
No. with + reactions:
0
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
Challenge: 100%
No. with + reactions:
0
Total no. in group:
20
Group:
positive control
Remarks on result:
not measured/tested

Following the challenge application of undiluted test substance and 50% (v/v) test substance in ethanol/diethylphthalate 1:1 (w/w), responses for all control and all test animals at the 24 and 48 hour observations were 0. The overall sensitisation rate was 0%.

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification according to regulation (EC) No 1272/2008
Conclusions:
Under the conditions of the guinea pig maximisation test the test substance revealed no sensitising properties.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The skin sensitising potential of the test substance was investigated in a guinea pig maximisation test (GPMT test) according to OECD Guideline 406 and in compliance with GLP (2001).

Based on the results of an range-finding study, animals were exposed intradermally and epicutaneously to the test substance (5% in peanut oil and 100%, respectively) or the vehicle. Two weeks later a challenge exposure with the test substance (50% in ethanol/diethylphthalate 1:1 (w/w) and 100%) for 24 h was performed. No skin reactions occured 24 h or 48 h after challenge in any animal. Therefore, the test substance is considered to be non-sensitising to the skin.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The available data on skin sensitisation of the test substance do not meet the criteria for classification according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.