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Diss Factsheets

Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
13 May 2002-13 June 2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study, GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2600 (Skin Sensitisation)
Deviations:
not specified
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Details on test material:
- Substance type: technical product
- Physical state: dark reddish-brown viscous liquid
- Lot/batch No.: no data; testing laboratory ID S02.001.3575
- Expiration date of the lot/batch: 04/07
- Storage condition of test material: room temperature

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Hartley-derived albino
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hilltop Lab Animals, Inc., Scottdale, PA
- Age at study initiation: males approximately 7 weeks; females approximately 9 weeks
- Weight at study initiation: males 396-483 g; females 393-458 g
- Housing: Individually in suspended stainless steel cages
- Diet (e.g. ad libitum): PMI Certified Guinea Pig Chow ~5026 (purina Mills, Inc.), ad libitum
- Water (e.g. ad libitum): municipal tap water treated by reverse osmosis, ad libitum
- Acclimation period: 5 days minimum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22
- Humidity (%): 36-77
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: mineral oil
Concentration / amount:
Concentration of test material used at induction: Intradermal injection: 5% w/w in mineral oil and 5% w/w in Freund's complete adjuvant emulsion
Epicutaneous application: 25% in mineral oil
Concentration of test material and vehicle used for each challenge: Challenge application: 0.5% and 0.2% w/w in mineral oil.
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: mineral oil
Concentration / amount:
Concentration of test material used at induction: Intradermal injection: 5% w/w in mineral oil and 5% w/w in Freund's complete adjuvant emulsion
Epicutaneous application: 25% in mineral oil
Concentration of test material and vehicle used for each challenge: Challenge application: 0.5% and 0.2% w/w in mineral oil.
No. of animals per dose:
Number of animals in test group: 10/sex
Number of animals in negative control group: 5/sex
Details on study design:
RANGE FINDING TESTS: Intradermal and topical range-finding studies were carried out in order to determine the concentrations to be used in the main studies.

MAIN STUDY
A. INDUCTION EXPOSURE - INTRADERMAL AND EPICUTANEOUS INDUCTION
- No. of exposures: 2 (1 intradermal and 1 epicutaneous)
- Exposure period: indefinite (intradermal); 48 hours (epicutaneous, occlusive cover)
- Test groups: 1
- Control group: yes
- Site: back
- Frequency of applications: single set of 6 injections (3 pairs) at day 0; single epicutaneous administration at day 8
- Duration: not applicable
- Concentrations: Injections 5% test substance in mineral oil or Freund's complete adjuvant emulsion; epicutaneous 25% test substance in mineral oil

B. CHALLENGE EXPOSURE
- No. of exposures: 1 upon challenge and 1 upon rechallenge
- Day(s) of challenge: day 21 and day 28
- Exposure period: approximately 24 hours
- Test groups: 1
- Control group: yes
- Site: back
- Concentrations: 0.5% in mineral oil (challenge) and 0.2% in mineral oil (rechallenge)
- Evaluation (hr after challenge/rechallenge): approximately 24 and 48
Challenge controls:
5/sex challenged with 0.5% in mineral oil; another group of 5/sex rechallenged with 0.2% in mineral oil (volume 0.3 ml in each case; occlusive cover). Evaluation after approximately 24 hours in each case.
Positive control substance(s):
yes
Remarks:
alpha-Hexylcinnamaldehyde; test not carried out concurrently with present study, but within 6 months. Induction at 5% in propylene glycol and challenge at 0.5% and 1% in propylene glycol.

Results and discussion

Positive control results:
A contact sensitization response was observed.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
.5 %
No. with + reactions:
6
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: .5 %. No with. + reactions: 6.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
.2 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: .2 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
.5 %
No. with + reactions:
4
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: .5 %. No with. + reactions: 4.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
.2 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: .2 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
.5 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: .5 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
.2 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: .2 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
.5 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: .5 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
.2 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: .2 %. No with. + reactions: 0.0. Total no. in groups: 10.0.

Any other information on results incl. tables

Maximum concentration not causing irritating effects in range finding intradermal injection test was 5% w/w in mineral oil. This was the highest concentration indicated under guidelines for the test; it produced no systemic toxicity and only localized reactions at the injection sites. In the range-finding epicutaneous study, concentrations of 1, 2.5, 5, 10, 25, 50, 75 and 100% were assessed. A concentration of 25% produced a mild to moderate [irritation] response; 0.5% apparently produced minimal irritation and was considered to be the "highest nonirritating concentration"; it was used as a challenge concentration.

 

Evidence of sensitization of each challenge concentration: Following challenge with 0.5% w/w test substance in mineral oil, dermal scores of 1 were noted in 6/20 animals at the 24-hour scoring interval. At the 48 hour scoring interval, dermal scores of 1 were noted in 4/20 animals. Dermal reactions in the remaining test and challenge control animals were limited to scores of 0 to +/- ("slight patchy erythema"; note this was seen in all of the challenge control animals at 24 hours). Group mean dermal scores were noted to be higher in the test animals as compared to the challenge control animals.

 

Following rechallenge with 0.2% w/w test substance in mineral oil, dermal reactions were limited to scores of 0 to +/- in all test and rechallenge control animals following the 24 and 48 hour scoring intervals.

 

Other observations: One rechallenge control animal was found dead on Day 9, but as the animal had been dosed with vehicle the death was not considered to be test-article related.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information weak sensitiser
Conclusions:
In a GLP study conducted according to EPA OPPTS 870.2600, the substance was considered to be a weak skin sensitiser in a guinea pig maximisation test
Executive summary:
In a GLP study conducted according to EPA OPPTS 870.2600, the substance was tested for dermal sensitisation potential in a guinea pig maximisation test. Briefly, animals (10/sex) were induced initially with intradermal injections of 5% in mineral oil and 5% in Freund's complete adjuvant emulsion and then, one week later, with topical administration of a concentration of 25% in mineral oil (under occlusive cover for 48 hours). After a rest period of two weeks, animals were challenged with topical administration of 0.5% in mineral oil. They were rechallenged after a further week with a concentration of 0.2% in mineral oil.

 

Upon challenge with 0.5% in mineral oil, 6/20 animals had dermal scores of 1 (slight, but confluent or moderate patchy erythema) after 24 hours, and only 4 animals retained this degree of redness after 48 hours. Dermal reactions in the remaining test and challenge control animals were limited to no or only "slight patchy erythema". There were no significant differences in reactions between treated and control animals upon rechallenge with 0.2% in mineral oil (at most only "slight patchy erythema" was seen, and this occurred in both test and rechallenge control animals).

 

In conclusion, the substance can be considered to be a weak skin sensitiser when tested in a guinea pig maximisation test.