4,7-methanooctahydro-1H-indene-diyldimethyl bis(2-carboxybenzoate)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1990-11-27 to 1990-12-04

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study. An updated OECD guideline from 2002 is available; changes do not affect the reliability of this study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

(1981)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

84/449/EEC

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4,7-methanooctahydro-1H-indene-diyldimethyl bis(2-carboxybenzoate)

EC Number:

407-410-2

EC Name:

4,7-methanooctahydro-1H-indene-diyldimethyl bis(2-carboxybenzoate)

Molecular formula:

C28H40O8

IUPAC Name:

2-[({5-[(2-carboxycyclohexanecarbonyloxy)methyl]tricyclo[5.2.1.0²,⁶]decan-8-yl}methoxy)carbonyl]cyclohexane-1-carboxylic acid; 2-[({8-[(2-carboxycyclohexanecarbonyloxy)methyl]tricyclo[5.2.1.0²,⁶]decan-4-yl}methoxy)carbonyl]cyclohexane-1-carboxylic acid

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): TCD-Emulgator
- Substance type: White solid
- Physical state: Solid
- Purity test date: 1990-04-26
- Lot/batch No.: 90003
- Expiration date of the lot/batch: 1992-01-08
- Storage condition of test material: At room temperature and in darkness
- pH: 5.0 (1 % in H2O)

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Interfauna U.K. Ltd., Wyton, Huntingdon, UK
- Age at study initiation: No data
- Weight at study initiation: 3.5, 3.2, and 3.6 kg, all female
- Housing: Individually in stainless steel cages
- Diet (e.g. ad libitum): Standard diet "Ssniff K 4", approx. 100-120 g per animal and day (fed in the morning)
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): Approx. 50 %
- Air changes (per hr): Approx. 10/h
- Photoperiod (hrs dark / hrs light): 12/12 (illumination from 6 to 18 hrs CET)

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg, moistened

Duration of treatment / exposure:

4 h

Observation period:

7 d

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 6 cm²
- Type of wrap if used: semiocclusive dressing (Fixomull-Stretch Klebevlies, Beiersdorf no. 2293)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): With water
- Time after start of exposure: 4 h

SCORING SYSTEM:
According to DRAIZE

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

0

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

0

Other effects:

No other effects.

Any other information on results incl. tables

Skin irritant effects of the TCD-emulsifier:

Animal No.	Body weight [kg]	Sex	Draize grade after												Irrit. index
			1 h		24 h		48 h		72 h		7 d		14 d
			e	o	e	o	e	o	e	o	e	o	e	o	e	o
L4	3.5	Female	0	0	0	0	0	0	0	0	0	0	-	-	0.0	0.0
L6	3.2	Female	0	0	0	0	0	0	0	0	0	0	-	-	0.0	0.0
K23	3.6	Female	0	0	0	0	0	0	0	0	0	0	-	-	0.0	0.0

e: erythema and eschar formation

o: oedema formation

-: not examined

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Irritant and/or corrosive effects of TCD-emulsifier were tested according to OECD uideline 404 and EU Method B.4. The test substance is not irritating to rabbit skin.

Executive summary:

In a primary dermal irritation study according to OECD guideline 404 and EU method B.4, adult albino rabbits (strain: HC:NZW) (3 female animals) were dermally exposed to 500 mg TCD-emulsifier in water for 4 hours, administered to 6 cm² at dorso-lateral areas of the animals' trunk. Animals then were observed for 7 days. Irritation was scored by the method of DRAIZE.

No irritation occurred. Based on the study results, TCD-emulsifier is not classified according to CLP Annex I as a dermal irritant.