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Diss Factsheets

Administrative data

Description of key information

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:
30 September to 12 November 1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
At the time the study was performed, a lower number of treated animals was required for non-adjuvant studies. As the number of induction exposures was higher than the normally used, and response in treated animals was clear, this deviation is considered to not affect the outcome of the study.
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
1981
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPP 81-6 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
The testing using the guinea pig maximisation test protocol was completed on 30 September 1986. The LLNA 429 was not formally adopted by the OECD until 22 July 2010.
Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Kuiper's Rabbit Ranch, Gary, Indiana, USA
- Age at study initiation: young adult
- Weight at study initiation (main study): 333 to 445 g
- Housing: individual in wire-mesh cages suspended above cage board
- Diet: Purina Certified Guinea Chow #5026 or Purina Certified Rabbit Chow #5322 supplemented three times a week with fresh apples ad libitum
- Water: tap water from on-site weels ad libitum
- Acclimation period: at least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature: 72 +/- 4 Fahrenheit degrees
- Humidity: 40% or more
- Photoperiod: 12 hours light/12 hours dark

IN-LIFE DATES: 30 September to 12 November 1986
Route:
epicutaneous, occlusive
Vehicle:
other: acetone
Concentration / amount:
25% for inductions (treated animals only) and 5% for challenge (treated and naive control animals)
0.25 (first 3 inductions) and 0.1% (w/v) in 80% ethanol for inductions (positive control animals) and 0.1% in 80% ethanol for challenge (positive control animals)
Route:
epicutaneous, occlusive
Vehicle:
other: acetone
Concentration / amount:
25% for inductions (treated animals only) and 5% for challenge (treated and naive control animals)
0.25 (first 3 inductions) and 0.1% (w/v) in 80% ethanol for inductions (positive control animals) and 0.1% in 80% ethanol for challenge (positive control animals)
No. of animals per dose:
6 males and 6 females for the treated group,
3 males and 3 females for the naive and positive control groups
Details on study design:
A total of 9 Induction exposures were performed on treated animals, each 2-3 days apart.
Challenge controls:
Naive control animals remained untreated during the induction phase. They were challenged with Dibromostyrene at 5% in acetone as the treated animals.
Positive control substance(s):
yes
Remarks:
1-chloro-2,4-dinitrobenzene
Positive control results:
All positive control animals exhibited sensitization responses at challenge, ranging from slight (grade 1) to severe (grade 3).
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
5% in acetone
No. with + reactions:
2
Total no. in group:
12
Clinical observations:
very slight reaction (grade +/-)
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5% in acetone. No with. + reactions: 2.0. Total no. in groups: 12.0. Clinical observations: very slight reaction (grade +/-).
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
5% in acetone
No. with + reactions:
5
Total no. in group:
12
Clinical observations:
very slight reaction (grade +/-)
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5% in acetone. No with. + reactions: 5.0. Total no. in groups: 12.0. Clinical observations: very slight reaction (grade +/-).
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
5% in acetone
No. with + reactions:
0
Total no. in group:
6
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 5% in acetone. No with. + reactions: 0.0. Total no. in groups: 6.0.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
5% in acetone
No. with + reactions:
1
Total no. in group:
6
Clinical observations:
very slight reaction (grade +/-)
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 5% in acetone. No with. + reactions: 1.0. Total no. in groups: 6.0. Clinical observations: very slight reaction (grade +/-).
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
1% in 80% ethanol
No. with + reactions:
6
Total no. in group:
6
Clinical observations:
grades 1 to 3
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 1% in 80% ethanol. No with. + reactions: 6.0. Total no. in groups: 6.0. Clinical observations: grades 1 to 3.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
1% in 80% ethanol
No. with + reactions:
6
Total no. in group:
6
Clinical observations:
grades 1 to 3
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 1% in 80% ethanol. No with. + reactions: 6.0. Total no. in groups: 6.0. Clinical observations: grades 1 to 3.

The Irritation Severity Index was also calculated for each group at each time point. At 24 hours the irritation severity index was 0.1, 0.0 and 1.8 in the treated, negative and positive control groups, respectively. At 48 hours the irritation severity index was 0.2, 0.1 and 1.8 in the treated, negative and positive control groups, respectively.

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
The test substance failed to reveal skin sensitization potential at challenge, following 9 exposure inductions, in a Buheler test.
Executive summary:

In a Buheler test, a group consisting of 6 male and 6 female Hartley albino guinea pigs was induced by topical application of the test substance at 25% in acetone for 9 times, 2 -3 days apart one from the other. The test material induced generally very slight to slight (grade +/- to grade 1) reactions during the induction phase, the incidence and severity of which increased as induction treatment progressed. Other findings of fissuring, desquamation and scabbing were noted during the induction phase. Treated and negative control animals were therefore challenged with the test substance at 5% in acetone applied to a previously unexposed area of skin. Only very slight reactions (grade +/-) were observed in 2 treated and 0 negative control animals at the 1st reading 24 hours after challenge. Very slight reactions (grade +/-) were observed in 5 treated and 1 negative control animals at the 2nd reading 48 hours after challenge. All the positive control animals showed evidence of skin sensitisation at both the 24 and 48 hours readings (grades 1 to 3), demonstrating test system sensitivity and appropriateness of the test method.

On these bases the test substance was considered to not be a skin sensitizer.

Endpoint:
skin sensitisation: in chemico
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:
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:

The key study, Naas D.J. (1987), was considered reliable and accurate as a standalone study to fulfil the data requirement. The study was conducted to OECD 406 and in compliance with GLP, accordingly the study was assigned a reliability score of 1.

Migrated from Short description of key information:

The test substance failed to reveal skin sensitization potential at challenge, following 9 exposure inductions, in a Buhler test.

Justification for selection of skin sensitisation endpoint:

A single good quality study was available to address the endpoint.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

According to the criteria in directive 67/548/EEC and regulation (EC) No 1272/2008, the substance does not meet the criteria for classification. The substance was found not to induce sensitisation when tested in animals, and there are no known concerns in humans.