Hydrocarbons, C9, aromatics

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1983/05/10-1983/05/03

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: According to OECD Guideline 406.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Deviations:

no

GLP compliance:

no

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

Scientifically valid and well documented guinea pig maximisation test

Test material

Test material information

Constituent 1

Reference substance name:

Hydrocarbons, C9, aromatics

EC Number:

918-668-5

Cas Number:

128601-23-0

Molecular formula:

C9H12

IUPAC Name:

Hydrocarbons, C9, aromatics

In vivo test system

Test animals

Species:

guinea pig

Strain:

Hartley

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Hazelton Dutchland, Inc.
- Sex: Female (30)
- Age at study initiation: Approximately 7 weeks
- Weight at study initiation: 352-437 g
- Housing: Individually
- Diet (e.g. ad libitum): Purina Guinea Pig Chow (pellets), ad libitum
- Water (e.g. ad libitum): Automatic watering system, ad libitum
- Acclimation period: 22 days


ENVIRONMENTAL CONDITIONS
- Temperature (°F): 65-71
- Humidity (%): 40-70
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal and epicutaneous

Vehicle:

other: Primol 185 (injection); neat (dermal application)

Induction 2

Concentration / amount:

Intradermal injection (max. tolerated dose: 5.0% (w/v) FCA (adjuvant)/MRD-83-208 and 5.0% (w/v) vehicle/MRD-83-208
Dermal Application: neat

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

other: Primol 185 (injection); neat (dermal application)

Challenge 2

Concentration / amount:

Intradermal injection (max. tolerated dose: 5.0% (w/v) FCA (adjuvant)/MRD-83-208 and 5.0% (w/v) vehicle/MRD-83-208
Dermal Application: neat

No. of animals per dose:

Control: Female (15)
Treatment: Female (15)

Details on study design:

INDUCTION EXPOSURE

INTRADERMAL INJECTION (DAY 0)
Site: 3 injections (0.1 ml/injection) on both sides of the spinal cord for a total of 6 paired injections
- Site 1: diluted FCA to both treated and control groups
- Site 2: 5.0% MRD-83-208 diluted in vehicle; and undiluted vehicle to control animals
- Site 3: Concentration: 5.0% MRD-83-208 in diluted FCA (adjuvant); and 5.0% vehicle in diluted FCA to the control group

INDUCTION BY OCCLUSIVE TOPICAL APPLICATION (DAY 7)
Experimental animals received 0.5 ml neat MRD-83-208 over the injection site under an occlusive wrap and held in place for 48 hrs. Control animals received 0.5 ml vehicle.

CHALLENGE EXPOSURE
Animals were challenged with either 0.5 ml 0.5% MRD-83-208 in vehicle or just vehicle (control group) that was topically applied to the clipped area on the right flank under an occlusive wrap for 24 hrs.

EXPERIMENTAL EVALUATION
Observations for toxicological signs occured immediately after dosing on day 0, 7, 10, 14, 21, and each time dermal observations were made. Body weights were recorded on days 0, 7, 14, 21, and at sacrifice. Dermal evaluations occured 24 hrs after the induction patch was removed (day 10) and 24 and 48 hrs after removal of the challenge patch. Dermal responses were evaluated by the Draize Method.

Challenge controls:

Vehicle controls were used for each of the induction treatments and for the challenge treatment.

Positive control substance(s):

no

Results and discussion

In vivo (non-LLNA)

Results

Results 1

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

negative control

Dose level:

0

No. with + reactions:

8

Total no. in group:

15

Clinical observations:

Slight erythema (score of 1 for all + animals)

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 8.0. Total no. in groups: 15.0. Clinical observations: Slight erythema (score of 1 for all + animals).

Results 2

Key result

Reading:

2nd reading

Hours after challenge:

48

Group:

negative control

Dose level:

0

No. with + reactions:

7

Total no. in group:

15

Clinical observations:

slight erythema (score of 1 for all + animals)

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 7.0. Total no. in groups: 15.0. Clinical observations: slight erythema (score of 1 for all + animals).

Results 3

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

0.5%

No. with + reactions:

10

Total no. in group:

15

Clinical observations:

slight erythema (score of 1 for all + animals except one that scored 2)

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5%. No with. + reactions: 10.0. Total no. in groups: 15.0. Clinical observations: slight erythema (score of 1 for all + animals except one that scored 2).

Results 4

Key result

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

0.5%

No. with + reactions:

7

Total no. in group:

15

Clinical observations:

slight erythema (score of 1 for all + animals)

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.5%. No with. + reactions: 7.0. Total no. in groups: 15.0. Clinical observations: slight erythema (score of 1 for all + animals).

Results 5

Key result

Group:

positive control

Remarks on result:

not measured/tested

Any other information on results incl. tables

Summary of other skin sensitisation studies

End Point

Study Reference

REACH requirement

IUCLID Section

Study Name

Data Waiving

Waiving Justification

Species

Study Result Type

Test Guideline/Qualifier

Test Guideline/Guideline

Test Guideline/Deviations

Reliability

Rational For Reliability

GLP Compliance

Test Materials/Identity

Study Result

Reference Type

Reference Author

Reference Year

Reference Title

Bibliographic Source

Testing Laboratory

Reference Report No.

Owner Company

Company Study No.

Report Date

Data access

8.3 Skin sensitization

7.4.1

Skin Sensitization

guinea pig

Experimental result

Equivalent or similar to

Magnusson, B., and Kligman, A.M., (1969). The identification of contact allergens by animal assay. The guinea-pig maximization test. J. Invest. Derm.,52, 268-276.

2

Summary only of study.

No data

Shellsol A

not sensitizing

Study report

Coombs, AD, Blair, D, Doak, SM, Carter, BI

1977

The Acute Toxicity of Shellsol A

HSPA0687

Sittingbourne Research Centre

M(T)-1-77

Shell Chemicals Europe BV

June, 1977

yes

Applicant's summary and conclusion

Interpretation of results:

other: Not sensitising

Conclusions:

Based on the scores of dermal irritation, test substance would not be considered a dermal sensitizer under either EU GHS guidelines or under the EU requirements for dangerous substances and preparations guidelines.

Executive summary:

A Hartley dermal sensitization test was conducted on 30 guinea pigs. Following a preliminary irritation test, 15 Hartley guinea pigs were treated by intradermal injection (0.01 ml; 5.0% (w/v) vehicle/MRD-83 -208 or with adjuvant) to induce sensitization and then further sensitized by dermal application of 0.5 ml MRD-83 -208 a week after the intradermal injection. Guinea pigs were challenged two weeks later by topical application (0.5 ml 0.5% MRD-83 -208). No indication of sensitization was noted. Based on the scored of dermal irritation, test substance MRD-83 -208 would not be considered a dermal sensitizer under either EU GHS guidelines or under the EU requirements for dangerous substances and preparations guidelines.