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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report equivalent or similar to OECD guideline (404): GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): MRD-91-947
- Physical state: colorless liquid
- Analytical purity: assumed 100%
- 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 Research Products.
- Age at study initiation: males (17-19 weeks), females (16-18 weeks)
- Weight at study initiation: 2.7 – 3.16 kg
- Housing: individually
- Diet (e.g. ad libitum): Agway certified diet R.C.A. rabbit – ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 22 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-21
- Humidity (%): 40-60
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
undiluted
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:
45 minutes, 24h, 48h, 72h, and 7 days post patch removal
Number of animals:
6 (2 male, 4 female)
Details on study design:
TEST SITE
- Area of exposure: dorsal surface from the shoulder region to the lumbar region
- Type of wrap if used: semiocclusive

REMOVAL OF TEST SUBSTANCE
- Washing (if done): water and paper towel
- Time after start of exposure: 4 hours


SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 through 72 hours
Score:
0.67
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 through 72 h
Score:
0.72
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 through 72 h
Score:
0
Irritant / corrosive response data:
Topical application elicited very slight erythema in one animal at the 45 minute interval. Erythema increased after the 45 minute interval. At the 24 hour interval, one animal was noted with well-defined erythema and two animals were noted with very slight erythema. At the 48 hour interval, one animal was noted with well-defined erythema and three animals with very slight erythema. Four animals were noted with very slight erythema at the 71 hour interval. Erythema decreased at the Day 7 interval; one animal was noted with very slight erythema. Edema was not noted at any observation point. Desquamation was noted for three animals at the Day 7 interval.
Other effects:
There were no animal deaths.

Any other information on results incl. tables

Individual Dermal Scores
45 min 24 H 48 H 72 H Day 7
Animal #1 (M) erythema 0 0 0 0 0
edema 0 0 0 0 0
Animal #2 (M) erythema 0 0 1 1 0
edema 0 0 0 0 0
Animal #3 (M) erythema 1 1 1 1 0
edema 0 0 0 0 0
Animal #4 (F) erythema 0 2 2 1 1
edema 0 0 0 0 0
Animal #5 (F) erythema 0 0 0 0 0
edema 0 0 0 0 0
Animal #6 (F) erythema 0 1 1 1 0
edema 0 0 0 0 0

Applicant's summary and conclusion

Interpretation of results:
other: not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The skin irritation potential for neodecanoic acid is minimal.
Executive summary:

Neodecanoic acid was administered via an occluded dermal patch to 6 rabbits at a dose of 0.5 ml neat solution for 4 hours to assess the skin irritation potential.   Dermal evaluations occurred at 45 minutes, 24h, 48h, 72h, and 7 days post patch removal. Application sites were graded for erythema, edema, and other signs of dermal irritation according to the Draize method of scoring.  Topical application elicited very slight erythema in one animal at the 45 minute interval.  Erythema increased after the 45 minute interval.  At the 24 hour interval, one animal was noted with well-defined erythema and two animals were noted with very slight erythema.  At the 48 hour interval, one animal was noted with well-defined erythema and three animals with very slight erythema.  Four animals were noted with very slight erythema at the 71 hour interval.  Erythema decreased at the Day 7 interval; one animal was noted with very slight erythema.  Edema was not noted at any observation point.  Desquamation was noted for three animals at the Day 7 interval.  The mean skin irritation scores between 24 and 72 hours were: erythema 0.72 and edema 0.