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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From Feb 14, 1990 to Feb 17, 1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPP 81-5 (Acute Dermal Irritation)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): MON 13900
- Physical state: Brown particles (powder)
- Lot/batch No.: DAY-8912-1370T
- Expiration date of the lot/batch: December, 1993 (estimated)
- Storage condition of test material: Room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Six young adult New Zealand White rabbits (4 males, 2 females), obtained from Mohican Valley Rabbitry, Loundonville,Ohio, were used in this study. The animals were individually housed in suspended stainless steel cages in an environment-controlled room with a 12–h light/dark cycle. Agway Prolab rabbit ration and fresh water were provided to each animal ad libitum. The rabbits were individually identified using plastic ear tags and cage cards. All animals were allowed to acclimate to the laboratory environment for a minimum of 5 d prior to initiation of the study.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
not required
Amount / concentration applied:
0.5 g of the test substance (moistened with 0.5 mL of distilled water)
Duration of treatment / exposure:
4 h
Observation period:
1, 24, 48 and 72 h
Number of animals:
6
Details on study design:
On the day prior to dosing, the fur was clipped from the dorsal area of the trunk of each animal using small animal clipper. Care was taken during clipping to avoid accidental abrasion to the skin. On the following day, the animals were weighed (animal weight ranged from 2.0-2.6kg) and two test sites measuring approx 1 inch x 1 inch were selected on the exposed skin of each rabbit. A dose of 0.5 g of the test substance (moistened with 0.5 mL of distilled water) was applied to the designated sites on each rabbit. Immediately after applying the test substance on each animal, a gauze patch was placed over the treated sites and secured to the adjacent skin, using nonirritating tape. A tubular stockinette sleeve (semi-occlusive binding) was then positioned around the trunk of the animal and this was positioned around the cut edges using tape. After an exposure period of 4 h, the stockinette sleeve and patches were removed from each animal. The test sites on each animal were then rinsed with distilled water to remove residual test substance. The test sites were examined for signs of erythema and edema at 1, 24, 48 and 72 h. All animals were sacrificed using T–61 euthanasia solution and discarded after completion of each animal’s final scoring interval.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 30-60 min, 24, 48 and 72 h
Score:
0.15
Max. score:
8
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal: #1-6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: #1-6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
Exposure to the test substance produced slight erythema on 7/12 test sites at the 1 h scoring interval. All dermal irritation resolved by 24 h post application.

Any other information on results incl. tables

Dermal irritation scores:

 

 

Time

 

Draize scores

Observation

(Hours)

Site

5459/M

5460/M

5463/M

5467/M

5479/F

5482/F

Erythema

1

1

0

1

0

1

0

1

 

 

2

0

1

1

1

0

1

 

24

1

0

0

0

0

0

0

 

 

2

0

0

0

0

0

0

 

48

1

0

0

0

0

0

0

 

 

2

0

0

0

0

0

0

 

72

1

0

0

0

0

0

0

 

 

2

0

0

0

0

0

0

Oedema

1

1

0

0

0

0

0

0

 

 

2

0

0

0

0

0

0

 

24

1

0

0

0

0

0

0

 

 

2

0

0

0

0

0

0

 

48

1

0

0

0

0

0

0

 

 

2

0

0

0

0

0

0

 

72

1

0

0

0

0

0

0

 

 

2

0

0

0

0

0

0

Overall mean scores

Erythema

Oedema

0.0

0.0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this test, MON 13900 is considered a negligible irritant to the skin of the rabbit with a primary dermal index of 0.15.
Executive summary:

A study was conducted to assess the potential skin irritation and/or corrosion effects of MON 13900 in rabbits according to OECD Guideline 404, EPA OPP 81-5 and EU Method B.4 in compliance with GLP.

The test substance was applied as a 0.5 g dose (moistened with 0.5 mL distilled water) to two clipped dermal sites on six New Zealand white rabbits. The substance was held in place under a semi-occlusive dressing for 4 h, after which the dressing was removed. Any remaining test substance was wiped from the skin using gauze and distilled water. The test sites were examined and scored for dermal irritation at 1, 24, 48 and 72 h. Exposure to the test substance produced slight erythema in 4/6 rabbits at the 1 h time point. All dermal irritation had resolved by 24 h post-application.

Under the conditions of the study, the test substance produced only minor irritation to skin, with a primary dermal index (PDII) of 0.15.