4,4'-Isopropylidenediphenol, polymer with 1-chloro-2,3-epoxypropane, propane-1,2-diol acrylate and succinic anhydride

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 18 March, 2004 to 26 March, 2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

Deviations from the minimum and maximum level of temperature occurred however, these deviations were considered not to have affected the study integrity.

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

Deviations from the minimum and maximum level of temperature occurred however, these deviations were considered not to have affected the study integrity.

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Deviations:

yes

Remarks:

Deviations from the minimum and maximum level of temperature occurred however, these deviations were considered not to have affected the study integrity.

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: JMAFF, Japanese Test Guidelines (2000)

Deviations:

not specified

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

4,4'-Isopropylidenediphenol, polymer with 1-chloro-2,3-epoxypropane, propane-1,2-diol acrylate and succinic anhydride

EC Number:

500-240-0

EC Name:

4,4'-Isopropylidenediphenol, polymer with 1-chloro-2,3-epoxypropane, propane-1,2-diol acrylate and succinic anhydride

Cas Number:

68958-77-0

Molecular formula:

UVCB, major component represented by di-functionalised BADGE (HPA-SA-BADGE-SA-HPA): C41H52O16 Other constituents present at >10%: Mono-functionalised BADGE (BADGE-SA-HPA): C35H44O14 Dimers (HPA-SA-BADGE-SA-BADGE-SA-HPA): C66H82O24

IUPAC Name:

2-Propenoic acid, monoester with 1,2-propanediol, polymer with 2-(chloromethyl)oxirane, dihydro-2,5-furandione and 4,4'-(1-methylethylidene)bis[phenol]

Test material form:

liquid

Test animals

Species:

rabbit

Strain:

other: New Zealand White, (SPF-Quality)

Details on test animals or test system and environmental conditions:

Age and body weight: Animals used within the study were at least 6 week old and body weights were at least 1000 mg.
Identification: Earmark
Conditions: Animals were housed in a controlled environment, in which optimal conditions were considered to be approx 15 air changes/h, a temperature of 21.0 ± 3.0°C (actual range: 17 - 24.1⁰C), a relative humidity of 30-70% (actual range: 33 - 66%) and 12 h artificial fluorescent light and 12 h darkness per day.
Accommodation: Individually in labeled cages with perforated floors (Scanbur, Denmark, dimensions 56x44x37.5 cm). Acclimatization period was at least 5 d before start of treatment under laboratory conditions.
Diet: Standard laboratory rabbit diet (Charles River Breeding and Maintenance Diet for Rabbits, Altromin, Lage, Germany) approx 100 g/day. Certificates of analysis were examined and retained in the NOTOX archives. In addition, pressed hay (BMI, Helmond, the Netherlands) was provided at least three times a wk.
Water: Free access to tap-water. Certificates of quarterly analysis were examined and retained in the NOTOX archives.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

500 mg

Duration of treatment / exposure:

4 h

Observation period:

Observations were made 1, 24, 48 and 72 h after exposure.

Number of animals:

3

Details on study design:

-Treatment: Approx 24 h before treatment, the dorsal fur was clipped with electric clippers, exposing an area of approx 150 square centimeters (10x15 cm2). Whenever considered necessary the treated skin areas were re-clipped at least 3 h before the observations, to facilitate scoring. A health inspection was performed prior to the commencement of treatment, to ensure that the animals were in a good state of health. Special attention was paid to the skin to be treated, which was intact and free from abnormalities. Each animal was treated by dermal application of 500 mg of the test substance. The test substance was applied to the skin of one flank, using a metalline patch of 2x3 cm. The patch was mounted on Micropore tape, which was wrapped around the abdomen and secured with Coban elastic bandage. 4 h after the application, the dressing was removed and the skin cleaned of residual test substance using water and watery ethanol (50% v/v).
-Observation:
Mortality/Viability: Twice daily.
Toxicity: At least once daily.
Body Weight: Day of treatment (prior to application) and at termination.
Irritation: The skin reactions were assessed at approximately 1, 24, 48 and 72 h after the removal of the dressings and test substance.The irritation scores and a description of all other (local) effects were recorded. Adjacent areas of the untreated skin of each animal served as controls.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible within: 48 hrs

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible within: 24hrs

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible within: 48 hrs

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Irritation: 4 h exposure to 500 mg of the test substance resulted in very slight erythema in the treated skin-areas of the three rabbits. No oedema was noted. The skin irritation had resolved within 48 h after exposure in all animals.
Corrosion: There was no evidence of a corrosive effect on the skin.
Colouration/remnants: No staining of the treated skin by the test substance was observed. Sticky remnants of the test substance were present on the skin on Day 1.

Other effects:

No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Any other information on results incl. tables

Mean value irritation scores (24, 48 and 72 h):

Animal #	Mean 24-72 h
	Erythema	Oedema
899	0.3	0
938	0.3	0
948	0.3	0
Primary irritation index: 0.3

 

Mean value irritation scores (24 and 72 h):

Animal #	Mean 24-72 h
	Erythema	Oedema
899	0.5	0
938	0.5	0
948	0.5	0
Primary irritation index: 0.5

Applicant's summary and conclusion

Interpretation of results:

other: CLP criteria not met (not irritating)

Conclusions:

Under the conditions of the study, the test substance was considered to be non-irritating to skin.

Executive summary:

A study was performed to assess the skin irritation potential of the substance '4,4'-Isopropylidenediphenol, polymer with 1-chloro-2,3-epoxypropane, propane-1,2-diol acrylate and succinic anhydride'according to OECD Guideline 404, EU Method B.4, US EPA, OPPTS 870.2500 and JMAFF Guidelines, in compliance with GLP. Three rabbits were exposed to 500 mg of the test substance, applied onto clipped skin for 4 h using a semi-occlusive dressing. Observations were made 1, 24, 48 and 72 h after exposure. Exposure to the test substance resulted in very slight erythema in the treated skin areas of the rabbits. No oedema was noted. The skin irritation had resolved within 48 h after exposure in all animals. Sticky remnants of the test substance were present on the skin, 1 h after exposure only. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred. Based on the 24, 48 and 72 h readings, the primary irritation index was calculated to be 0.3. Based on the 24 and 72 h readings, the primary irritation index was calculated to be 0.5. Under the conditions of the study, the test substance was considered to be non-irritating to skin (Huygevoort, 2004).