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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: guideline study, GLP, full report available. Also assessed by OECD.

Data source

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

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Specific details on test material used for the study:
- Physical state: yellowish, solid
- Analytical purity: 99.7%
- Purity test date: 10 jan 1989

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Breeder Interfauna UK, Ltd. Wyton, Huntington, England
- Weight at study initiation: 300-340 g
- Housing: Indiviudally housed in stainless stell cages or polyethylene cages.
- Diet (e.g. ad libitum): Standard diet Ssniff K 4 approx 100-120 g/animal/day; once per day in the morning.
- Water (e.g. ad libitum): Tap water
- Acclimation period: Prior to the initiation of treatment the animals were kept for at least 14 days in the quarantine station and monitored.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 deg C
- Humidity (%): approx 50%
- Air changes (per hr): 10 times per hour
- Photoperiod (hrs dark / hrs light):12 hours, artificial illumination from 6 to 18hrs CET


Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Amount / concentration applied:
Concentration: 500 mg
Duration of treatment / exposure:
4 hour(s)
Observation period:
24, 48 and 72 hours after exposure
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6cm2
- Type of wrap if used: Semi occlusive dressing (Fixomull Stretch Klebevlies, Beiersdorf no, 2293)


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Carefully washed with water without altering the existing response or the integrity of the epidermis.
- Time after start of exposure: 4 hours


SCORING SYSTEM:
- The degree of erythema/eschar formation and odema formation was recorded as specified by DRAIZE and any serious lesions or toxic effects other than dermal irritation were also recorded.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1h
Score:
0
Max. score:
0
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24h
Score:
0
Max. score:
0
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 48h
Score:
0
Max. score:
0
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72h
Score:
0
Max. score:
0
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 7 d
Score:
0
Max. score:
0
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 14 d
Score:
0
Max. score:
0
Irritant / corrosive response data:
No erythema or eshar formation and no odema formation

Any other information on results incl. tables

no signs of irritation appeared within 7 days

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
not irritating
Executive summary:

The irritant/corrosive effects of test substance Disflamoll TP were tested on the skin of rabbits in accordance with OECD Guideline 404. Interpretation was based on the nature, intensity and reversibility of the responses. In this study, the test substance was not irritating to the skin of rabbits following an exposure period of 4 hours.