Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
27 Sept 1994 to 28 Oct 1994
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
(1992)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPP 81-6 (Skin Sensitisation)
Version / remarks:
(1984)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OTS 798.4100 (Skin Sensitisation)
Version / remarks:
(1989)
Deviations:
no
Qualifier:
according to
Guideline:
other: JMAFF 59 NohSan No. 4200 (Guidance on toxicology study data for application of agriculture chemical registration) (1985)
Deviations:
no
GLP compliance:
yes
Type of study:
Buehler test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Technical Grade MKH 3586
- Physical state: Beige powder
- Analytical purity: 98.2%
- Purity test date: 17 Jun 1994
- Lot/batch No.: 17004/93
- Expiration date of the lot/batch: 6 months from date of purity testing

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
Neat (test material not diluted)
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
Neat (test material not diluted)
No. of animals per dose:
Induction and challenge: 10 animals/sex
Challenge: 5 animals/sex

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
other: Induction and challenge
Dose level:
Neat test material
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
None
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: Induction and challenge. Dose level: Neat test material. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None.
Reading:
2nd reading
Hours after challenge:
48
Group:
other: Induction and challenge
Dose level:
Neat test material
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
None
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: Induction and challenge. Dose level: Neat test material. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None.
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
other: Induction and challenge
Dose level:
Neat test material
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
None
Remarks on result:
other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: other: Induction and challenge. Dose level: Neat test material. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None.
Reading:
1st reading
Hours after challenge:
24
Group:
other: challenge
Dose level:
Neat test material
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: challenge. Dose level: Neat test material. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
Reading:
2nd reading
Hours after challenge:
48
Group:
other: challenge
Dose level:
Neat test material
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: challenge. Dose level: Neat test material. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
other: challenge
Dose level:
Neat test material
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None
Remarks on result:
other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: other: challenge. Dose level: Neat test material. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.

Any other information on results incl. tables

OBSERVATIONS:

Clinical / skin:

No clinical signs of toxicity or other lesions were observed. At each of the 24, 48 and 72 hour scorings for the three induction exposures no erythema was observed in any test animal. Following the challenge dose, both the test and non-induced animals were judged to be free of erythema at 24, 48 and 72 hours post exposure. Subsequently, both male and female test animals had an incidence index of 0.0 and a severity index of 0.0 following the challenge dose.

 

Bodyweight:

No test material related effects observed.

 

Mortality:

All animals survived to the end of the experimental phase.

Applicant's summary and conclusion

Conclusions:
Based on the results of this Buehler topical-closed patch study MKH 3586 did not have any potential to cause dermal sensitisation in guinea pigs.
Executive summary:

In a Buehler topical closed-patch study MKH 3586 was assessed for its potential to induce skin sensitisation. The test and non-induced control groups consisted of 10 animals/sex and 5 animals/sex, respectively, with the test material administered undiluted as a solid (0.4g) moistened with deionised water just prior to application. Animals in the test group received 3 topical applications for induction on days 0, 7 and 14 followed by a 14-day rest period, followed by topical challenge on day 28. Animals in the non-induced control group received only the challenge application on day 28.

 

There was no test material related effect on body weight. No other toxic lesions or effects were observed.

 

No erythema was evident in either sex following any of the 3 induction exposures. No erythema was observed at the dose site of any of the test or non-induced control animals after the challenge dose. Therefore, the test animals had an incidence index of 0.0 and a severity index of 0.0 following the challenge dose.

 

Based on the results of this Buehler topical-closed patch study MKH 3586 did not have any potential to cause dermal sensitisation in guinea pigs.