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Diss Factsheets

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:
1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
e study was not conducted according to guideline/s and GLP but the report contains sufficient data for interpretation of study results

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report date:
1973

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of divinylbenzene and ethylstyrene
EC Number:
910-757-7
Cas Number:
N/A
Molecular formula:
Divinylbenzene: C10H10 Ethylstyrene: C10H12
IUPAC Name:
Reaction mass of divinylbenzene and ethylstyrene
Details on test material:
Vapor phase chromatograph (VPC) analysis :
Divinylbenzene 55.7%, Ethylvinylbenzene 40.4%, Diethylbenzene 4.5%, Mass 144-146 1.7%, Naphthalene 0.4%, t-Butyl Catechol 1010 ppm, Polymer 4 ppm

The percentage was determined by measuring the percent area of each component shown in the vapor phase chromatograph and is
considered to be approximately equal to weight percent.


Test animals

Species:
rabbit
Strain:
not specified
Details on test animals or test system and environmental conditions:
No data

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: shaved, abraded and unabraded
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
1-2 mL
Duration of treatment / exposure:
unabraded, intact skin - 5 days per week for 2 weeks
abraded skin- daily for 3 days
ear - daily 5 days per week for 2 week
Observation period:
Condition of the skin, at the exposure sites, was assessed and the severity of the reaction recorded daily, 5 days per week, during the esposure period and also at the end of the 3 week study. The animals were weighed at weekly intervals and were frequently observed to detect any changes in behavior and general appearance.
Number of animals:
3
Details on study design:
The abdominal skin of three rabbits was shaved free of hair using a straight razor and barber soap. The animals were rested for several days to permit healing of minute razor abrasions. Fresh amounts of the DVB (1-2 mL) were applied each day to an intact and an abraded exposure site on each animal under an absorbent cotton pad held in place by a cloth bandage taped to the animal's trunk. In the case of the intact skin, the test material was applied 5 days per week for 2 weeks which represents a continuous exposure of 14 days. The exposure to abraded skin was repeated daily for 3 days. Daily applications, 5 days per week for 2 weeks, were likewise made to the inner surface of the rabbit ear. Condition of the skin, at the exposure sites, was assessed and the severity of the reaction recorded daily, 5 days per week, during the exposure period and also at the end of the 3-week study. The animals were weighed at weekly intervals and were frequently observed to detect any changes in behaviour and general appearance.

Results and discussion

In vivo

Resultsopen allclose all
Remarks on result:
probability of mild irritation
Irritation parameter:
erythema score
Basis:
animal: all animals
Time point:
24/48/72 h
Remarks on result:
other: Slight erythema was observed at the 24-hour observation. Repeated application resulted in slight erythema, very slight necrosis and moderate exfoliation onintact abdominal skin. Moderate necrosis was observed on abraded skin.
Irritation parameter:
edema score
Basis:
animal: all animals
Time point:
24/48/72 h
Remarks on result:
other: Repeated application resulted in slight edema on the intact abdominal skin site.
Irritant / corrosive response data:
Twenty-four hours after the first application, little irritation was seen on the rabbits' ears. Slight erythema was observed at all the abdominal sites at the 24-hour observation. Repeated application resulted in slight erythema, slight edema, very slight necrosis and moderate exfoliation on the ear and intact abdominal skin site. The response at the abraded skin sites was greater in that moderate necrosis was observed. No signs of toxicity other than topical effects were observed during the course of the skin irritation study.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
Twenty-four hours after the first application of DVB-55, little irritation was seen. Prolonged skin contact with the test material would likely result in slight redness and slight swelling.
Executive summary:

The abdominal skin of three rabbits was shaved free of hair using a straight razor and barber soap. The animals were rested for several days to permit healing of minute razor abrasions. Fresh amounts of the DVB (1-2 mL) were applied each day to an intact and an abraded exposure site on each animal under an absorbent cotton pad held in place by a cloth bandage taped to the animal's trunk. In the case of the intact skin, the test material was applied 5 days per week for 2 weeks which represents a continuous exposure of 14 days. The exposure to abraded skin was repeated daily for 3 days. Daily applications, 5 days per week for 2 weeks, were likewise made to the inner surface of the rabbit ear. Condition of the skin, at the exposure sites, was assessed and the severity of the reaction recorded daily, 5 days per week, during the exposure period and also at the end of the 3-week study. The animals were weighed at weekly intervals and were frequently observed to detect any changes in behaviour and general appearance.

Twenty-four hours after the first application, little irritation was seen on the rabbits' ears. Slight erythema was observed at all the abdominal sites at the 24-hour observation. Repeated application resulted in slight erythema, slight edema, very slight necrosis and moderate exfoliation on the ear and intact abdominal skin site. The response at the abraded skin sites was greater in that moderate necrosis was observed. No signs of toxicity other than topical effects were observed during the course of the skin irritation study.