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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Remarks:
An existing in vivo ski irritation / corrosivity study was available.
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1 August 1983 to 18 October 1983
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Exxon biomedical sciences inc.

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hazleton dutchland inc, Denver PA
- Age at study initiation: Approximately 22 weeks
- Weight at study initiation: 3.06 to 3.5 kg
- Housing: Individual, Steel housing
- Diet (e.g. ad libitum): Purina Rabbit chow HF, ab libitum
- Water (e.g. ad libitum): Automatic watering system, ab libitum
- Acclimation period: 71 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 21 °C
- Humidity (%): 40 to 70%
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark

IN-LIFE DATES: From: 1 August 1983 to 18 October 1983

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): Assumed 100%
Duration of treatment / exposure:
4 hours
Observation period:
60 min, 24, 48, 72 hour, 7 day
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: Dorsal surface from the shoulder region to the lumbar region
- % coverage: 5 % of total body
- Type of wrap if used: Gauze patch and plastic sleeve

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not washed

OBSERVATION TIME POINTS
(indicate if minutes, hours or days) 60 min, 24, 48, 72 hour, 7 day

SCORING SYSTEM:
- Method of calculation: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 60 min
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 60 m
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 60 m
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 7 d
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 7d
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
7 d
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 7 d
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: 60 min
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
other: 60 m
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritant / corrosive response data:
Dermal exposure to MRD-83-308 elicited very slight (barely perceptible) erythema in all animals. Positive dermal irritation scores were recorded for all animals at the 24 hour observation interval. By the day 7 readings only 1 animal continued to show signs of dermal irritation.

The primary irritation index for the 24 and 72 hour observations were calculated to be 0.67.
Other effects:
There were no deaths noted during this study. Five of the 6 test animals displayed an increase in body weight during the 7 day test period.

Any other information on results incl. tables

Results tables can be found in the attachment to this RSS.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Dermal exposure to MRD-83-308 elicited very slight (barely perceptible) erythema in all animals. Positive dermal irritation scores were recorded for all animals at the 24 hour observation interval. By the day 7 readings only 1 animal continued to show signs of dermal irritation.

The primary irritation index for the 24 and 72 hour observations were calculated to be 0.67.
Executive summary:

The primary skin irritation potential of MRD-83-306 was evaluated following its application to the clipped backs of six New Zealand white rabbits. The test material was topically administered to an intact site on the back of each animal, covered with gauze and secured with a plastic sleeve for 4 hours. After exposure was completed the plastic sleeve and gauze were removed and the test site was graded for erythema, edema and other signs of dermal irritation at approximately 60 minutes, 24, 48 and 72 hours following patch removal. Dermal readings were also made on day 7. All dermal scoring was made according to the Draize method of scoring.

 

Dermal exposure to MRD-83-306 elicited very slight (barely perceptible) erythema for all animals at the 24 hour observation interval. Only one animal showed signs of dermal irritation through to day 7.

 

Based on these findings the primary irritation index was 0.67. The primary skin irritation potential of MRD-83-306 was evaluated following its application to the clipped backs of six New Zealand white rabbits. The test material was topically administered to an intact site on the back of each animal, covered with gauze and secured with a plastic sleeve for 4 hours. After exposure was completed the plastic sleeve and gauze were removed and the test site was graded for erythema, edema and other signs of dermal irritation at approximately 60 minutes, 24, 48 and 72 hours following patch removal. Dermal readings were also made on day 7. All dermal scoring was made according to the Draize method of scoring.

 

Dermal exposure to MRD-83-306 elicited very slight (barely perceptible) erythema for all animals at the 24 hour observation interval. Only one animal showed signs of dermal irritation through to day 7.

 

Based on these findings the primary irritation index was 0.67.