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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:
1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Pre-GLP study following a method equivalent to a recognised OECD guideline. Deviations to recognised guideline are noted.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Occlusive dressing smaller exposure area (2.5cm2), longer exposure period (24h) shorter observation period (48h)
Qualifier:
according to
Guideline:
other: 16 CFR 1500.41
Deviations:
no
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Physical state: liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Recognised animal supplier
- Age at study initiation: at least 8 weeks
- Weight at study initiation:
- Housing: housed 2/cage in suspended wire mesh cages (30" x 18" x 18")
- Diet: rabbit chow ad libitum
- Water: ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 21
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): not reported

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped / abraded
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): neat (liquid)
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
2 males; 4 females (6 in total)
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm2
- % coverage: Not reported. The fur was clipped from the backs and sides of the animals. The back to the left of the spinal column of all animals was abraded. The abrasions, extending the length of the exposure site, scratched the stratum corneum but did not reach the derma or produce bleeding. The back to the right of the spinal column remained intact.
- Type of wrap if used: Occlusive (gauze wrapped with imperivous material)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not reported
- Time after start of exposure: Not applicable.

SCORING SYSTEM: Draize-scoring system. The mean values (6 rabbits) for erythema/eschar and edema formation on intact and abraded skin at 24 and 72 hours (a total of 8 values) are added and divided by 4 to give the Primary lrritation score. By the criteria of this test, Primary lrritant means a substance which is not corrosive, but which results in an empirical score of 5 or more. References: 16 CFR 1500.41 and 16 CFR 1500.3.

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Score:
1.88
Max. score:
8
Reversibility:
no data
Irritant / corrosive response data:
Very slight to well defined erythema and very slight edema was noted during the observation period.

Any other information on results incl. tables

Table 1. Skin reactions (using Draize scoring method)

Erythema & Eschar Formation Hours Rabbit number Mean score
1 2 3 4 5 6
Intact skin 24 1 1 1 1 1 1 1.00
72 1 2 1 1 2 2 1.50
Abraded skin 24 1 1 1 1 1 1 1.00
72 1 2 1 0 1 1 1.00
 
Edema                
Intact skin 24 1 1 1 1 1 1 1.00
72 0 1 0 0 1 1 0.50
Abraded skin 24 1 1 1 1 1 1 1.00
72 0 1 0 0 1 1 0.5
                 
Sum of mean scores 7.50
Primary irritation index = sum of mean scores/4 1.88

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: US CPSC / US FDA
Conclusions:
Under the conditions of this study the test substance is not considered to be irritating to the skin of New Zealand white rabbits.
Executive summary:

The non-GLP study was completed under 16 CFR 1500.41 following a guideline similar to OECD 404, to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The test substance was evaluated in 6 New Zealand white rabbits. A dose of 0.5 ml test substance was applied to intact and abraded clipped dorsal skin site under a occlusive dressing for 24 hours. Skin observations were made 24 and 72 hours after patch removal. Very slight erythema and edema were noted at 24 hours in both intact and abraded skin. By 72 hours, very slight to well defined erythema and very slight edema were observed in both intact and abraded skin. The test material produced a mean primary irritation index (PII) of 1.88 and is considered to be non-irritating to skin.