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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:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1985/11/18 - 1986/01/03
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report in agreement with OECD guideline 406-GLP.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
The first-choice method according to REACH Annex VII §8.3, the Murine Local Lymph Node Assay, is known to give false positive results with hydrocarbon substances.
Species:
guinea pig
Strain:
Hartley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: CAMM Research Laboratory Animals, Wayne, NJ 07470
- Age at study initiation: young adults
- Weight at study initiation: 284-331g
- Housing: individually
- Diet (e.g. ad libitum): fresh Certified Purina guinea pig chow #5026, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 15 days, induction phase animals; 7 days, dose selection phase animals

ENVIRONMENTAL CONDITIONS
-Temperature: 64 to 74 degrees F
-Humidity: 29 to 62 percent relative humidity
-Photoperiod: 12hrs dark/12hrs light
Route:
epicutaneous, occlusive
Vehicle:
other: mineral oil
Concentration / amount:
Induction: 0.5 ml, neat
Challenge: 0.5 ml, neat
Route:
epicutaneous, occlusive
Vehicle:
other: mineral oil
Concentration / amount:
Induction: 0.5 ml, neat
Challenge: 0.5 ml, neat
No. of animals per dose:
Dose selection: 6
Induction/challenge: 20
Challenge control: 8
Details on study design:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Test groups: 1 (receiving 0.5 ml of undiluted test article)
- Control group: 2 (challenge control and positive control (0.3% DNCB in 80% ethanol/water))
- Site: along a side of the dorsal midline
- Frequency of applications: Weekly
- Duration: Three weeks

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Day 14 post induction applications
- Exposure period: 6 hours
- Test groups: 1 (receiving 0.5 ml of undiluted test article)
- Control group:2 (Challenge control and positive control (0.2% DNCB in 80% ethanol/water))
- Site: Naive area along a side of the dorsal midline
- Evaluation (hr after challenge): 24- and 48-hours post-application, challenge sites were scored for erythema and edema according to the Draize technique
Positive control substance(s):
yes
Remarks:
2,4 dinitrochlorobenzene (2,4 DNCB)
Positive control results:
Response grades, severity and incidence at the time of the challenge exposure for DNCB resulted in a significantly higher response in the induction/challenge group than that observed in the naive challenge control group.

DNCB:
Challenge: 24 h reading: 3.2 (response grade), 10/10 animals
48 h reading: 2.4 (response grade), 10/10 animals
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.5 mL neat
No. with + reactions:
9
Total no. in group:
9
Clinical observations:
Avg. combined erythema/edema score = 2.0
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5 mL neat. No with. + reactions: 9.0. Total no. in groups: 9.0. Clinical observations: Avg. combined erythema/edema score = 2.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.5 mL neat
No. with + reactions:
8
Total no. in group:
9
Clinical observations:
Avg. combined erythema/edema score = 0.9
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.5 mL neat. No with. + reactions: 8.0. Total no. in groups: 9.0. Clinical observations: Avg. combined erythema/edema score = 0.9.
Reading:
1st reading
Hours after challenge:
24
Group:
other: challenge control
Dose level:
0.5 mL
No. with + reactions:
4
Total no. in group:
4
Clinical observations:
Avg. combined erythema/edema score = 2.0
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: challenge control. Dose level: 0.5 mL. No with. + reactions: 4.0. Total no. in groups: 4.0. Clinical observations: Avg. combined erythema/edema score = 2.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
other: challenge control
Dose level:
0.5 mL
No. with + reactions:
4
Total no. in group:
4
Clinical observations:
Avg. combined erythema/edema score = 1.2
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: challenge control. Dose level: 0.5 mL. No with. + reactions: 4.0. Total no. in groups: 4.0. Clinical observations: Avg. combined erythema/edema score = 1.2.
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
0.3% DNCB
No. with + reactions:
10
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Remarks on result:
not measured/tested
Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the test, the test article F-64-01 was not a delayed contact sensitizer and the positive control DNCB was a delayed contact sensitizer.
Executive summary:

Male Hartley Albino guinea pigs were dermally exposed to test article F-64-01 neat at a volume of 0.5 ml for each of three induction phases. For the challenge phase, the test article was administered undiluted for both the induction/challenge and challenge control group animals. Response grades, severity and incidence at the time of the challenge exposure for the test article F-64-01 indicated no dermal responsiveness in the induction/challenge group above that observed in the naive challenge control group. The naive challenge irritation control group animals were also free of any dermal response. Response grades, severity and incidence at the time of the challenge exposure for DNCB resulted in a significantly higher response in the induction/challenge group than that observed in the naive challenge control group.

Under the conditions of the test, the test article F-64-01 was not a delayed contact sensitizer and the positive control DNCB was a delayed contact sensitizer.

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report similar or equivalent to OECD 406. GLP.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
Buehler test
Species:
guinea pig
Strain:
Hartley
Sex:
male
Route:
epicutaneous, occlusive
Vehicle:
other: mineral oil
Concentration / amount:
Induction dose: 0.5 ml, neat
Challenge dose: 0.5 ml, 1:2 dilution in mineral oil

Positive Control DNCB:
Induction/Challenge: 0.05% DNCB in ethanol
Route:
epicutaneous, occlusive
Vehicle:
other: mineral oil
Concentration / amount:
Induction dose: 0.5 ml, neat
Challenge dose: 0.5 ml, 1:2 dilution in mineral oil

Positive Control DNCB:
Induction/Challenge: 0.05% DNCB in ethanol
No. of animals per dose:
10 males for induction/challenge
Details on study design:
A. INDUCTION EXPOSURE
- No. of exposures: 10
- Exposure period: 6 hours
- Frequency of applications: three times per week
- Duration: 3 weeks


B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Day 14 post-induction application
- Exposure period: 6 hours
- Evaluation (hr after challenge): 24 and 48 hr

OTHER: response grade score = erythema + edema
Challenge controls:
Naive guinea pigs receiving only the challenge dose in order to distinguish between “background” irritation response and actual allergenic response.
Positive control results:
Most of the positive control group animals showed evidence of sensitization.
Remarks on result:
other: see Any other information on results below

Since the challenge treatment did not produce scores higher than the sensitizing treatment, the test substance was considered to be non-sensitizing.

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Unleaded motor gasoline (API PS-6) did not induce a sensitisation response in guinea pigs in this study. This finding does not warrant the classification of the test article as a skin sensitiser under Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
Executive summary:

Male Hartley Albino guinea pigs were dermally exposed to unleaded motor gasoline (API PS-6), neat, at a volume of 0.5 ml for each of the three induction phases. For the challenge phase, unleaded motor gasoline was administered as a 1:2 dilution in mineral oil for the challenge and challenge control group animals. Response grades, severity and incidence at the time of the challenge exposure for the test article indicated no dermal responsiveness in the induction/challenge group above that observed in the naive challenge control group. Response grades, severity and incidence at the time of the challenge exposure for DNCB resulted in a significantly higher response in the induction/challenge group than that observed in the naive challenge control group. This finding does not warrant the classification of unleaded motor gasoline (API PS-6) as a skin sensitiser under Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations. 

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

In a read-across sensitisation study with gasoline, there was no evidence of dermal sensitization in a Buehler test in guinea pigs

Migrated from Short description of key information:

Skin sensitization – Not sensitizing in guinea pig (OECD TG 406).

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

In a read-across guinea pig sensitisation study with gasoline there was no evidence of dermal sensitisation. Thus, the data available do not support classification as a sensitiser according to EU CLP Regulation (EC No. 1272/2008).