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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Remarks:
An adequate in vivo study was conducted on MTDID 15670 prior to the requirement for in vitro data.
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: CFR 16 Section 1500.41
Deviations:
no
Principles of method if other than guideline:
Six rabbits received test material on one abraded and one intact test site. The site of administration was clipped of hair and the test material was held in place with 1 inch x 1 inch gauze, adhesive tape, and an impervious material such as rubberized cloth was wrapped around the torse of the rabbit. After 24 hours of exposure the patches were removed and the sites were scored for erythema and edema (0-4 scales). Observations are recorded at 24 and 72 hours after the exposure period.
GLP compliance:
no
Remarks:
The study was conducted prior to the widespread adoption of GLP.

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: No data
- Expiration date of the lot/batch: No data
- Purity test date: No data

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: None

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: No data
- Age at study initiation: No data
- Weight at study initiation: No data
- Housing: No data
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: No data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data

IN-LIFE DATES: No data

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

NEGATIVE CONTROL
- Amount(s) applied (volume or weight): None
Duration of treatment / exposure:
24 hours
Observation period:
Observations were recorded 24 and 72 hours post-exposure.
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: Trunk
- Type of wrap if used: Occlusive:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No data
- Time after start of exposure: Test substance exposure was reported as 24 hours.

OBSERVATION TIME POINTS: Observations were recorded 24 and 72 hours post-exposure.

SCORING SYSTEM:
- Method of calculation: Erythema: 0-4, Edema: 0-4

Erythema
0: No erythema
1: Very slight erythema (barely perceptible)
2: Well-defined erythema
3: Moderate to severe erythema
4: Severe erythema (beet redness) to slight eschar formation (injuries in depth)

Edema
0: No edema
1: Very light edema (barely perceptible)
2: Slight edema (edges of area well-defined by definite raising)
3: Moderate edema (raised approximately 1 mm)
4: Severe edema (raised more than 1 mm and extending beyond the area of exposure)

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24/72 hour
Score:
ca. 5
Reversibility:
not specified
Remarks on result:
probability of moderate irritation
Irritant / corrosive response data:
Erythema (scores: 2-3) and edema (scores: 1-3) were observed at all treated sites at both observation times. Blanching of the skin was observed in intact sites (4 animals) and abraded sites (5 animals) at 24 hours post-exposure. Blanching and cracked skin was observed in 3 animals at 72 hours post-exposure. The PDII was 5.0.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
Based on the results of the study, MTDID 15670 is a moderate skin irritant.
Executive summary:

The dermal irritation potential of MTDID 15670 (unknown form, lot unknown) was evaluated in rabbits. The study design was based on the recommendations in US CFR Title 16, Section 1500.41. Six hair clipped rabbits received test material on one abraded and one intact test site. The test material was held in place with 1 inch x 1 inch gauze, adhesive tape, and an impervious material such as rubberized cloth was wrapped around the torso of the rabbit. After 24 hours of exposure the patches were removed and the sites were scored for erythema and edema (0-4 scales). Observations are recorded at 24 and 72 hours after the exposure period and the scores of all sites are averaged together to produce the primary dermal irritation index (PDII) . Animals were not observed beyond 72 hours after exposure. Erythema (scores: 2-3) and edema (scores: 1-3) were observed at all treated sites at both observation times. Blanching of the skin was observed in intact sites (4 animals) and abraded sites (5 animals) at 24 hours post-exposure. Blanching and cracked skin was observed in 3 animals at 72 hours post-exposure. The PDII was 5.0. Based on the results of this study, MTDID 15670 is a moderate skin irritant.