Extracts (petroleum), heavy naphthenic distillate solvent

Skin sensitisation

Administrative data

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study is classified as reliable without restriction because it was conducted similar to OECD Test Guideline 406.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

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.

Test material

Test material information

Constituent 1

Reference substance name:

64742-05-8

IUPAC Name:

64742-05-8

Constituent 2

Reference substance name:

Light paraffinic distillate solvent extract

IUPAC Name:

Light paraffinic distillate solvent extract

Test material form:

liquid: viscous

Details on test material:

- Name of test material (as cited in study report): API 83-16, CAS No. 64742-05-8
- Physical state: Liquid, amber
- Viscosity, SSU: 67.2 at 100°F
- API Gravity: 16.7
- Flash Point: (°F) 335
- Pour Point (°F): 20
- Aniline Point (°F): 95.5
- Sulfur, Wt %: 2.64

- Composition of test material ASTM D-2007, Wt. %:
Saturates: 29.2
Aromatics 68.6

In vivo test system

Test animals

Species:

guinea pig

Strain:

Hartley

Sex:

male

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Hazleton Dutchland, Inc., Denver, Pennsylvania
- Age at study initiation: 5 to 6 weeks old
- Weight at study initiation: 435 to 598 grams
- Housing: Individual cages
- Diet (e.g. ad libitum): Purina certified guinea pig chow 5026, ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: At least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 to 24
- Humidity (%): 37 to 62
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 04-02-1985 To: 15-03-1985

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

epicutaneous, occlusive

Vehicle:

paraffin oil

Induction 2

Concentration / amount:

50% v/v mixture in paraffin oil (sensitising application)
1% v/v mixture in paraffin oil (challenge dose)

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

paraffin oil

Challenge 2

Concentration / amount:

50% v/v mixture in paraffin oil (sensitising application)
1% v/v mixture in paraffin oil (challenge dose)

No. of animals per dose:

10 animals

Details on study design:

RANGE FINDING TESTS: Consisted of eight guinea pigs, with each animal receiving 2 concentrations of test material. Originally administered undiluted and at 25%, 50%, and 75% v/v in paraffin oil. Because of irritation at the 25% level, additional concentrations of 10% v/v and 1% v/v were needed to determine irritation threshold. No dermal irritation resulted from the 1% v/v applications. The 10% and 25% v/v applications produced very slight irritation responses. The 25%,50%, and 75% v/v applications produced very slight to well-defined responses. Based upon these results, the test material was administered as a 50% v/v mixture (mild to moderately irritating) in paraffin oil for the sensitising applications and as 1% v/v mixture (the highest non-irritating concentration) in paraffin oil for the challenge dose.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Test groups: 10 guinea pigs
- Control group: Paraffin oil administered undiluted (0.4mL)
- Site: Back, left anterior quadrant of prepared site on back
- Frequency of applications: One application per week for 3 weeks
- Duration: 3 weeks
- Concentrations: 50% v/v in paraffin oil

B. CHALLENGE EXPOSURE
- No. of exposures: Single exposure
- Day(s) of challenge: Two weeks (14 days)
- Exposure period: 6 hours
- Test groups: Same 10 animals that received induction dose
- Control group: Dosed with test material in the same manner
- Site: Right anterior quadrant of prepared site on back
- Concentrations: 1% v/v in paraffin oil
- Evaluation (hr after challenge): 24 hours after, 3 hours prior to the 24-hour examination, the test site of each animal was depilated for 20 minutes and washed with lukewarm water

Challenge controls:

10 animals (previously untreated) were dosed with the test material mixture in the same manner as the test group.

Positive control substance(s):

yes

Remarks:

2,4-dinitrochlorobenzene

Results and discussion

Positive control results:

The erythema and oedema scores during the sensitising phase ranged from 1.7 to 2.0 and 1.0 to 1.8, respectively. The erythema and oedema scores for the challenge phase are 1.0 to 2.5 and 0 to 1.5, respectively.

In vivo (non-LLNA)

Results

Results 1

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

1% v/v

No. with + reactions:

8

Total no. in group:

10

Clinical observations:

oedema scores were all 0.0, erythema scores ranged from 0.0 to 1.0

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1% v/v. No with. + reactions: 8.0. Total no. in groups: 10.0. Clinical observations: oedema scores were all 0.0, erythema scores ranged from 0.0 to 1.0.

Results 2

Reading:

1st reading

Hours after challenge:

24

Group:

negative control

Dose level:

1% v/v

No. with + reactions:

9

Total no. in group:

10

Clinical observations:

oedema scores are all 0.0, erythema scores ranged from 0.0 to 1.0

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 1% v/v. No with. + reactions: 9.0. Total no. in groups: 10.0. Clinical observations: oedema scores are all 0.0, erythema scores ranged from 0.0 to 1.0.

Results 3

Reading:

1st reading

Hours after challenge:

24

Group:

positive control

Dose level:

0.1% v/v

No. with + reactions:

20

Total no. in group:

20

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.1% v/v. No with. + reactions: 20.0. Total no. in groups: 20.0.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based upon the similar results obtained from the challenge phase and the naive control, light paraffinic distillate solvent extract is not sensitising to guinea pig skin according to EU criteria.

Executive summary:

Light paraffinic DAE (CAS number 64742-05-8) was tested on 10 Hartley guinea pigs for sensitization in a Buehler test. The procedure used was a closed patch test closely following the Buehler test method outlined in OECD Guideline 406. The animals were divided into six groups: test group (10), naïve control group (10), vehicle control (10), positive control (20) and finally a naïve positive control group (20). In the test group (8/10) animals displayed very slight erythema; the highest reaction did not exceed the highest reaction of the naïve control animals. No reaction was observed in 2/10 animals. Animals in the naïve control group (9/10), vehicle control group (3/10), displayed very slight erythema. No reaction was seen in the rest of animals in each group. The positive control group (20/20) showed slight to severe irritation. The reactions of all animals equalled or exceeded the highest reaction observed in the naïve positive control group (4/19). Since the challenge reactions of the test animals did not exceed the highest reactions of control animals in any of the two naïve groups, it was concluded that the test substance was not sensitizing.

 

This study received a Klimisch score of 1 and is classified as reliable without restriction because it was conducted similar to OECD Test Guideline 406.