Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1979-09-21 to 1979-10-27
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable with restrictions because it was conducted similar to guideline study OECD 406.
Justification for type of information:
See read-across justification provided in section 13.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
not specified
Type of study:
other: buehler type dermal application
Justification for non-LLNA method:
The available Buehler type test provides information on skin sensitisation potential by measuring challenge-induced dermal hypersensitivity reactions elicited in test animals compared with controls.
Species:
guinea pig
Strain:
other: albino
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: CAMM Research Institute
- Age at study initiation: young adult
- Weight at study initiation: not reported
- Housing: housed in stainless steel cages with indirect bedding
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 10 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): not reported
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): not reported


IN-LIFE DATES: not reported
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.5 mL of undiluted test material
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.5 mL of undiluted test material
No. of animals per dose:
10 treatment animals and 10 positive control animals
Details on study design:
RANGE FINDING TESTS: not reported

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10
- Exposure period: 6 hours
- Test groups: 10 animals in treatment group
- Control group: 10 animals in positive control group
- Site: back
- Frequency of applications: three times per week
- Duration: three weeks
- Concentrations: undiluted


B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: two weeks after induction period
- Exposure period: 6 hours
- Test groups: 10 animals in treatment group
- Control group: 10 animals in positive control group
- Site: backs
- Concentrations: undiluted
- Evaluation (hr after challenge): 24 hours
Positive control substance(s):
yes
Remarks:
0.05% (w/v) dilution of chlorodinitrobenzene in ethanol
Positive control results:
No statistically significant differences between the mean of the averages of the ten sensitizing treatments and the mean of the challenge treatment for either erythema or oedema in the control group.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
undiluted
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
Average erythema score of 1.3 and average oedema score of 0.3.
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: undiluted. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: Average erythema score of 1.3 and average oedema score of 0.3..
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.05% w/v dilution of chlorodinitrobenzene in ethanol
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
Average erythema score = 1.9, Average oedema score = 0.7
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.05% w/v dilution of chlorodinitrobenzene in ethanol. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: Average erythema score = 1.9, Average oedema score = 0.7 .

Phase

Average Dermal Irritation Score

API #79 -6

Positive Control

Erythema

Oedema

Erythema

Oedema

Induction Phase Average

1.3

0.3

1.3

0.3

Challenge Phase Average

1.3

0.3

1.9

0.7

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Results indicated no statistically significant differences between the mean of the averages of the ten sensitizing treatments and the mean of the challenge treatment for either erythema or oedema in the test or control group. Based on this data, the test material is considered non-sensitising.
Executive summary:

In a skin sensitisation study, ten young adult male albino guinea pigs were exposed to 0.5 mL of undiluted diesel fuel (marketplace sample) in the treatment group and ten young adult male albino guinea pigs were exposed to 0.05% (w/v) dilution of chlorodinitrobenzene in ethanol in the positive control group. Both groups were shaved in an area on their back. On the day of application, test material or positive control was placed on a gauze patch which was put on the shaved exposure site, covered with plastic wrap and wrapped with elastic bandaging. Bandaging and wrapping was removed 6 hours after application. The same procedure was replicated 3 times a week for 3 weeks (10 treatments in total). Two weeks after the last induction dose, a single challenge dose was administered following the same methods as used during the induction period, in both the treatment and positive control groups. Scoring of erythema and oedema was made at 24 hours after each application.

Results indicated no statistically significant differences between the mean of the averages of the ten sensitizing treatments and the mean of the challenge treatment for wither erythema or oedema in the test or control group. Based on this data, the test material is considered non-sensitising.

This study received a Klimisch score of 2 and is classified as reliable with restrictions because it was conducted similar to guideline study OECD 406.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:
Migrated from Short description of key information:
In a repeat dermal application Buehler study with diesel fuel in guinea pigs, there was no evidence of dermal sensitisation.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

There was no evidence of dermal sensitisation following repeated application of diesel fuel in guinea pigs.