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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1989/12/12 - 1990/1/31
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: In agreement with OECD test guideline 404. GLP

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Hydrocarbons, C10-C13, aromatics, >1% naphthalene
EC Number:
926-273-4
IUPAC Name:
Hydrocarbons, C10-C13, aromatics, >1% naphthalene

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
Source: Hazleton Research Products
Sex: Male (3), Female (3)
Age at study initiation: Approximately 12 weeks
Weight at study initiation: 2.00-3.00 kg
Housing: Individually
Diet (e.g. ad libitum): Agway Certified Diet R.C.A. Rabbit (pellets), restricted as per recommendation of supplier
Water (e.g. ad libitum): Automatic watering system, ad libitum
Acclimation period: 22d

ENVIRONMENTAL CONDITIONS
Temperature (°F): 65 to 74
Humidity (%): 30-70%
Photoperiod (hrs dark / hrs light): 12/12
Monitored at least once a day

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
Amount(s) applied (volume or weight): 0.5 ml
Concentration (if solution): neat
Duration of treatment / exposure:
Test material was administered to the clipped backs as a single dose introduced under a gauze patch (secured with non-irritating tape) and held in contact with the skin by means of a semi-occlusive dressing for 4 hours. Residual test material was then removed.
Observation period:
45 min, 24, 48, and 72h post application and once per day on Day 7
Number of animals:
Male (3), Female (3)
Details on study design:
SCORING SYSTEM: Draize scale for dermal irritation

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1 hour
Score:
ca. 1
Max. score:
2
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 hours
Score:
ca. 1
Max. score:
2
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 hours
Score:
ca. 0.83
Max. score:
2
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 Hours
Score:
ca. 2
Max. score:
2
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: Day 7
Score:
ca. 0.67
Max. score:
1
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1 hour
Score:
ca. 0.33
Max. score:
1
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 hours
Score:
ca. 0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48 hours
Score:
ca. 0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 hours
Score:
ca. 0.17
Max. score:
1
Irritation parameter:
edema score
Basis:
mean
Time point:
other: Day 7
Score:
ca. 0
Max. score:
0
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24-72 hour
Score:
ca. 0.94
Irritant / corrosive response data:
Topical application of MRD-89-524 elicited dermal responses in 4 out of 6 animals. At the 1, 24, and 72 hour observations two animals were noted with a well defined erythema and very slight edema. One animal was noted with well defined erythema and three animals were noted with very slight erythema at the 48 hour observation. At day 7, four animals were noted with very slight erythema.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The average erythema score (24,48, and 72 hours) was 0.94. The average edema score (24,48, and 72 hours) was 0.06. Classification as a dermal irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
Executive summary:

In this study, 6 rabbits were subjected to a 4h dermal (shaved) exposure of 0.5 ml of MRD-89-524 via a semi-occluded patch. Dermal responses were evaluated at 1, 24, 48, and 72h post-dosing and on day 7 according to the Draize method of scoring. At the 1, 24, and 72 hour observations two animals were noted with a well defined erythema and very slight edema.  One animal was noted with well defined erythema and three animals were noted with very slight erythema at the 48 hour observation.  At day 7, four animals were noted with very slight erythema. The average erythema score (24,48, and 72 hours) was 0.94. The average edema score (24,48, and 72 hours) was 0.06. Classification as a dermal irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.