reaction mass of 1-chloro-3-(dodecyloxy)propan-2-ol andalpha-dodecyl-omega-hydroxy-di[oxy[(chloromethyl)-1,2-ethanediyl]] andalpha-dodecyl-omega-hydroxy-tri[oxy[(chloromethyl)-1,2-ethanediyl]]

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

14 November - 14 December 2006

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP study conducted in compliance with OECD Guideline 404 with minor deviation: the temperature and relative humidity recorded in the animal room was sometimes outside of the target ranges; individual animal weights not reported.

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:

2007

Report date:

2007

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

the temperature and relative humidity recorded in the animal room was sometimes outside of the target ranges; individual animal weights not reported.

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

yes

Remarks:

The temperature and relative humidity recorded in the animal room was sometimes outside of the target ranges; individual animal weights not reported

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

reaction mass of 1-chloro-3-(dodecyloxy)propan-2-ol and alpha-dodecyl-omega-hydroxy-di[oxy[(chloromethyl)-1,2-ethanediyl]] and alpha-dodecyl-omega-hydroxy-tri[oxy[(chloromethyl)-1,2-ethanediyl]]

Cas Number:

63727-39-9

Molecular formula:

C15H31ClO2 C18H36Cl2O3 C21H41Cl3O4

IUPAC Name:

reaction mass of 1-chloro-3-(dodecyloxy)propan-2-ol and alpha-dodecyl-omega-hydroxy-di[oxy[(chloromethyl)-1,2-ethanediyl]] and alpha-dodecyl-omega-hydroxy-tri[oxy[(chloromethyl)-1,2-ethanediyl]]

Test material form:

other: liquid

Details on test material:

- Physical state: Thick colorless to pale yellow liquid
- Date of receipt: 12 October 2006
- Expiration date of the lot/batch: 04 October 2007
- Storage condition of test material: Room temperature
- pH of the undiluted test item, measured (paper pH), was approximately 1.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Grimaud frères selection S.A.S., Roussay, France.
- Age at study initiation: 2-4 months
- Weight at study initiation: 2.8 ± 0.3 kg
- Housing: Animals were housed individually in Pajon cages (50 cm x 57 cm x 75 cm).
- Diet: Control Reference 110 pelleted diet (SAFE, Epinay-sur-Orge, France), ad libitum
- Water: Drinking water filtered by a FG Millipore membrane (0.22 µm), ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: Approximately 18 ± 3 °C
- Humidity: 30-70 %
- Air changes: Approximately 12 cycles/h of filtered, non-recycled air
- Photoperiod: 12 h dark / 12 h light

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 (weight with unit): 0.5 mL
- Concentration (if solution): Undiluted test item

Duration of treatment / exposure:

First animal: 3 minutes, 1 and 4 h
Second and third animal: 4 h

Observation period:

15 days

Number of animals:

3 males

Details on study design:

TEST SITE
- Area of exposure: Flank region
- Type of wrap if used: Undiluted test item was placed on a dry gauze pad, which was then applied to an area of approximately 6 cm^2 of the anterior left flank (application for 3 minutes), the anterior right flank (application for 1 h) and the posterior right flank (application for 4 h) of the animals. The gauze pad was held in contact with the skin by means of an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage.

REMOVAL OF TEST SUBSTANCE
- After removal of the dressing applied for 3 minutes, any residual test item was wiped off by means of a dry cotton pad. No residual test item was observed on removal of the dressing applied for 1 or 4 h.
- Time after start of exposure: 4 h

SCORING SYSTEM: According to OECD Guideline 404

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

2.7

Max. score:

4

Reversibility:

fully reversible within: 15 days

Results 2

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 10 days

Results 4

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 5

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 15 days

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritant / corrosive response data:

- After a 3-minute exposure (one animal), very slight or well-defined erythema was noted from Day 1 until Day 8. Dryness of the skin was observed from Day 5 until Day 15 (end of the observation period).
- After a 1-h exposure (one animal), very slight to moderate erythema was noted from Day 1 until Day 8. Dryness of the skin was observed from Day 4 until Day 15 (end of the observation period).
- After a 4-h exposure (three animals), well-defined to moderate erythema was noted in all the animals from Day 1 until Day 7 (2 animals) or Day 9 (1 animal) then very slight erythema persisted until Day 9 (1 animal) or Day 14 (2 animals). Dryness of the skin was recorded in all the animals between Day 4 and Day 15 (end of the observation period).

Other effects:

None

Any other information on results incl. tables

The test item was first evaluated on a single animal (No. 730). The durations of exposure were 3 minutes, 1 and 4 h. Since the test item was irritant but not corrosive on this first animal, it was then applied sequentially for 4 h to two other animals (No. 750 then No. 749).

See attached Document for Tables of Results

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the test conditions, the test item is classified as "R38: irritating to skin" according to the criteria of Annex VI to the Directive 67/548/EEC and classified "Category 2: irritant" according to CLP Regulation (EC) N° (1272-2008).

Executive summary:

In a GLP-compliant primary dermal irritation study performed according to OECD Guideline 404, three male New Zealand White rabbits were dermally exposed to 0.5 mL of undiluted test item under a semi-occlusive dressing. The test item was first evaluated on a single animal and the duration of exposure was 3 minutes, 1 and 4 h on the flank region. Since the test item was irritant but not corrosive on this first animal, it was then applied sequentially for 4 h to two other animals. After removal of the residual test item, irritation was scored as outlined in the OECD Guideline 404 at 1, 24, 48 and 72 h and up to 15 days after exposure.

 

After a 3-minute exposure (one animal), very slight or well-defined erythema was noted from Day 1 until Day 8. Dryness of the skin was observed from Day 5 until Day 15 (end of the observation period). After a 1-h exposure period (one animal), very slight to moderate erythema was noted from Day 1 until Day 8. Dryness of the skin was observed from Day 4 until Day 15 (end of the observation period). After a 4-h exposure (three animals), a well-defined to moderate erythema was noted in all the animals from Day 1 until Day 7 (2 animals) or Day 9 (1 animal) then a very slight erythema persisted until Day 9 (1 animal) or Day 14 (2 animals). Dryness of the skin was recorded in all the animals between Day 4 and Day 15 (end of the observation period). Mean scores over 24, 48 and 72 h for each animal were 2.7, 2.0 and 2.0 for erythema and 0.0, 0.0 and 0.0 for edema. The test item is therefore a skin irritant on male rabbits.

 

Under the test conditions, test item, 75418/10 is classified as "R38: irritating to skin" according to the criteria of the Annex VI to the Directive 67/548/EEC and classified for "Skin irritation: Category 2" according to the CLP Regulation (EC) N° (1272-2008).