Registration Dossier

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:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
no
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent

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)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: Primol 185 (injection); neat (dermal application)
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
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: Primol 185 (injection); neat (dermal application)
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

Study design: in vivo (LLNA)

Statistics:
The mean and standard deviations of the body weights were calculated.

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
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).
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).
Reading:
1st reading
Hours after challenge:
24
Group:
test group
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).
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
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).

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:
not sensitising
Remarks:
Migrated information
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.