2-[methyl[(nonafluorobutyl)sulphonyl]amino]ethyl methacrylate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

13 November 2001-28 January 2002

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study conducted under GLP conditions. Because these substances exhibit similarity in their physicochemical properties and toxicological properties in mammals, data gaps for mammalian toxicity can be addressed by read across. The read across is considered reliable with restrictions and the result is suitable for use in Risk Assessment, Classification & Labelling, and PBT Analysis.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-[methyl[(nonafluorobutyl)sulphonyl]amino]ethyl acrylate

EC Number:

266-733-5

EC Name:

2-[methyl[(nonafluorobutyl)sulphonyl]amino]ethyl acrylate

Cas Number:

67584-55-8

Molecular formula:

C10H10F9NO4S

IUPAC Name:

2-{methyl[(nonafluorobutyl)sulfonyl]amino}ethyl acrylate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report:T-7600
- Substance type: white powder
- Physical state: solid
- Composition of test material, percentage of components: > 97% 2-Propenoic acid, 2-[Methyl[(nonafluorobutyl)sulfonyl]amino]ethyl ester, <2% water, <0.01% Phenothiazine
- Lot/batch no.: Lot 1
- Expiration date of the lot/batch: 06 August 2002
- Stability under test conditions: not indicated
- Storage condition of test material: At room temperature in the dark.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Sex : Male
- Source: Charles River Deutschland, Kisslegg, Germany.
- Age at study initiation: at least 6 weeks old
- Weight at study initiation:between 1.0 and 3.5 kg
- Fasting period before study:
- Housing:- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 3 degrees C
- Humidity (%):30-70%, with temporary deviations due to room cleaning (does not affect study integrity)
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hours artificial light/12 hours dark
IN-LIFE DATES: From: 13 November 2001 To: 16 November 2001

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 grams of the test substance moistened with 0.5 ml of 50% ethanol in water.

Duration of treatment / exposure:

4 hours

Observation period:

up to 72 hours

Number of animals:

3/sex/dose

Details on study design:

TEST SITE
- Area of exposure: approx. 150 square centimeters
- % coverage:
- Type of wrap if used: the metalline patch was mounted on micropore tape and wrapped around the abdomen and secured with Coban elastic bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): skin cleaned using water
- Time after start of exposure: 4 hours
SCORING SYSTEM: Erythema and eschar formation (scale 0-4; 4 being severe erythema) and Edema formation (scale 0-4; 4 being severe edema)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

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:

No irritation or corrosion of the skin was observed during this study.

Any other information on results incl. tables

No mortality or systemic toxicity symptoms were observed during this study.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Skin irritation results for C4 sulfonamido acrylate (CAS 67584-55-8) are reported for read across to C4 sulfonamido methacrylate (CAS 67584-59 -2). Based on the results of this study and according to the EC criteria for classification and labelling requirements, the test substance does not have to be classified and has no obligatory labeling requirement for skin irritation.

Executive summary:

Skin irritation results for C4 sulfonamido acrylate (CAS 67584-55-8) are reported for read across to C4 sulfonamido methacrylate (CAS 67584-59 -2). The primary skin irritation/corrosion potential of T-7600 was assessed in the rabbit (4-hour semi-occlusive application). The study was carried out based on the guidelines described in EC Commission Directive 92/69/EEC, B.4 and OECD No. 404. Three male rabbits were exposed to 0.5 grams of the test article, applied onto clipped skin for 4 hours using a semi-occlusive dressing. Observations were made 1, 24, 48 and 72 hours after exposure. No mortality, systemic toxicity, corrosive effects or skin irritation was caused by 4 hours exposure to the test article.

Based on the results of this study and according to the EC criteria for classification and labelling requirements, the test substance does not have to be classified and has no obligatory labeling requirement for skin irritation.

Because these substances exhibit similarity in their physicochemical properties and toxicological properties in mammals, data gaps for mammalian toxicity can be addressed by read across. The read across is considered reliable with restrictions and the result is suitable for use in Risk Assessment, Classification & Labelling, and PBT Analysis