Sodium salts of Mono- and di-[reaction products of dodecyl alcohol and ethylene oxide]phosphates

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:

weight of evidence

Study period:

From 28 February 2000 to 27 October 2003

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study is a screening test but followed international guidance requirements with acceptable restrictions.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

: Screening test: only one animal is tested, no certificate of analysis included

Principles of method if other than guideline:

not applicable

GLP compliance:

no

Test material

Test material information

Constituent 1

Test material form:

other: Liquid at ambient temperature

Details on test material:

- Name of test material (as cited in study report): Dermalcare MAP L-213/K
- Physical state: clear liquid
- Stability under test conditions: assumed to be stable by the sponsor
- Storage condition of test material: ambient temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Italia S.p.A
- Age at study initiation: no data
- Weight at study initiation: 2.3 kg
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

IN-LIFE DATES: From: To: no data

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): not applicable

VEHICLE
not applicable

Duration of treatment / exposure:

4h

Observation period:

7 days

Number of animals:

1

Details on study design:

TEST SITE
- Area of exposure: 6.25 cm²
- % coverage: no data
- Type of wrap if used: test item was spread on a gauze square, placed onto the animal's skin and held in place by encircling the trunk of the animal with a length of elastic adhesive bandage

REMOVAL OF TEST SUBSTANCE
not applicable

SCORING SYSTEM: Draize scale

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Erythema was observed in the tested animal, but not edema (see table 7.3.1/1)

Other effects:

none

Any other information on results incl. tables

Table 7.3.1/1:Irritant/corrosive response data at each observation time after each exposure time.

Score at time point (from the start of exposure) / Reversibility	Erythema	Edema
	Max. score: 4	Max. score: 4
1 h	0	0
24 h	2	0
48 h	2	0
72 h	2	0
7 days	0	0
Average 24h, 48h, 72h	2.0	0.0
Reversibility*)	c	-
Average time (day) for reversion**	7	-

 *) Reversibility: c. = completely reversible; n.c.= not completely reversible; n. = not reversible

**) Corresponds to the last day on which skin irritation signs in the last animal were observed

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the test conditions, Dermalcare MAP L-213/K was irritating to the rabbit skin. The mean erythema score (2.0) obtained in the one tested rabbit (screening test) does not allow to classify Dermalcare MAP L-213/K as a skin irritant according to the crieria of the Regulation (EC) 1272/2008 (CLP) but allows to classify as Xi, R38 according to the criteria of the Directive 67/548/EEC.

Executive summary:

In a dermal irritation screening study performed similarly to the OECD guideline No. 404, one New Zealand White rabbit was dermally exposed to 0.5 mL of undiluted Dermalcare MAP L-213/K on a part of the trunk (6.25 cm²).Test site was covered with a semi-occlusive dressing for 4hours. The animal was then observed for 7 days. Skin irritation was assessed and scored according to the Draize scale at 1, 24, 48 and 72 hrs after the removal of the patch.

The mean score calculated within 3 scoring times (24, 48 and 72 hrs) was 2.0 for erythema and 0.0 for edema.

 

Under the test conditions, Dermalcare MAP L-213/K was irritating to the rabbit skin. The mean erythema score (2.0) obtained in the only one tested rabbit (screening test) do not permit to classify Dermalcare MAP L-213/K as a skin irritant according to the criteria of the Regulation (EC) 1272/2008 (CLP) but permit to classify as Xi, R38 according to the criteria of the Directive 67/548/EEC.