Alcohols C13-15 (branched and linear, odd numbered), reaction product with 1-chloro-2,3-epoxypropane

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1988-08-01 to 1988-08-05

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD Guideline test in compliance with GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Alcohols, C13-15 (odd numbered, branched and linear)

Molecular formula:

C13H28O and C15H32O

IUPAC Name:

Alcohols, C13-15 (odd numbered, branched and linear)

Constituent 2

Reference substance name:

Alcohols, C13, branched glycidyl ethers

Molecular formula:

C16H32O2

IUPAC Name:

Alcohols, C13, branched glycidyl ethers

Constituent 3

Reference substance name:

[(tridecyloxy)methyl]oxirane

EC Number:

276-765-1

EC Name:

[(tridecyloxy)methyl]oxirane

Cas Number:

72689-40-8

Molecular formula:

C16H32O2

IUPAC Name:

2-[(tridecyloxy)methyl]oxirane

Constituent 4

Reference substance name:

Alcohols, C15, branched glycidyl ethers

Molecular formula:

C18H36O2

IUPAC Name:

Alcohols, C15, branched glycidyl ethers

Constituent 5

Reference substance name:

[(pentadecyloxy)methyl]oxirane

EC Number:

302-058-5

EC Name:

[(pentadecyloxy)methyl]oxirane

Cas Number:

94088-56-9

Molecular formula:

C18H36O2

IUPAC Name:

2-[(pentadecyloxy)methyl]oxirane

Constituent 6

Reference substance name:

secondary reaction products of Oxirane, mono{[C13-15 (odd numbered, linear and branched)-alkyloxy)methyl] derivs.

Molecular formula:

UVCB, not applicable

IUPAC Name:

secondary reaction products of Oxirane, mono{[C13-15 (odd numbered, linear and branched)-alkyloxy)methyl] derivs.

Constituent 7

Reference substance name:

unknown constituents

IUPAC Name:

unknown constituents

Test material form:

liquid

Specific details on test material used for the study:

- Name of test material: Alkyl (C13-C15) - glycidylether
- Physical state: Liquid
- Analytical purity: >99%
- Lot/batch No.: DC 1295.3
- Stability under test conditions: Stable

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Madoer in AG. CH 4414 Fuellinsdorf / Switzerland
- Age at study initiation: male (14 weeks); females ( 15 weeks)
- Weight at study initiation: male (2.4 kg); females (2.5 - 2.6 kg)
- Housing: Individually in stainless steel cages equipped with an automatic cleaning and drinking system.
- Diet: ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ±3 °C
- Humidity (%): 40 - 70%
- Air changes (per hr): Air-conditioned with 10 - 15 air changes per hour.
- Photoperiod: 12 hours artificial fluorescent light; 12 hours dark.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.5 ml

Duration of treatment / exposure:

4 hours

Observation period:

7 days

Number of animals:

1 male and 2 females

Details on study design:

Approximately 24 hours before treatment, the dorsal fur was shaved with an electric clipper, exposing an area of approximately 100 square centimeters (10 cm ×10 cm).
On test day 1, 0.5 ml of the test article was applied to the intact skin of the shaved area. It was covered with a 3 cm × 3 cm patch of surgical gauze.
Four hours after the application, the dressing was removed and the skin was flushed with lukewarm tap water.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

>= 1 - <= 2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: Average score: 1.3

Results 2

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: Average score: 0

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: Average score: 1

Results 4

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: Average score: 0

Results 5

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: Average score: 1

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

>= 0 - <= 1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: Average score: 0.3

Irritant / corrosive response data:

Local signs (mean 1 hour to 7 days) consisted of grade 0.87 erythema and grade 0.13 edema.
Slight to moderate scales at the skin of the application area were observed in all animals at day 7 after the test article treatment.

Any other information on results incl. tables

Skin irritation scores:

Time period	Animal	Sex	Erythema	Edema	Cumulative Score	Mean Cumulative Score
1HR	4	M	1	0	1	1.33
	5	F	1	0	1
	6	F	1	1	2
24HRS	4	M	1	0	1	1.33
	5	F	1	0	1
	6	F	1	1	2
48HRS	4	M	1	0	1	1
	5	F	1	0	1
	6	F	1	0	1
72HRS	4	M	2	0	2	1.33
	5	F	1	0	1
	6	F	1	0	1
7 DAYS	4	M	0	0	0	0
	5	F	0	0	0
	6	F	0	0	0

Skin irritation: mean scores

Animal	Sex	Erythema	Edema	Cumulative Score	Mean Cumulative Score
4	M	1.33	0	1.33	1.22
5	F	1	0	1
6	F	1	0.33	1.33

Selected observations for mean scores: 24h, 48h and 72h.

Irritation

Alkyl (C13-C15)-glycidylether showed a primary irritation score of 1.22 when applied undiluted to intact rabbit skin.

Local signs (mean 1 hour to 7 days) consisted if grade 0.87 erythema and grade 0.13 edema.

Coloration

In the area of application no staining of the treated skin by pigment or coloring of the test article was observed.

Body weights

The body weight gain of all rabbits was similar.

Toxic symptoms / mortality

No acute toxic symptoms were observed in the animals during the test period, and no mortality occurred.

Necropsy

No necropsy was performed at termination of observation.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The study result indicated that Alkyl (C13-C15) -glycidylether was not irritating to the skin of rabbits.

Executive summary:

This study was conducted according to OECD guideline and EU method in order to evaluate the irritation potential of Alkyl (C13-C15)–glycidylether to the skin. 1 male and 2 female rabbits were used in the study. 0.5 ml of the substance was applied to the intact skin of the shaved areas of the each rabbit for 4 hours and the untreated skin areas of the rabbit serve as the control. All rabbits were examined for signs of erythema and oedema at 24, 48 and 72 hours after patch removal.

The results showed that the substance caused slight erythema during the examination period; however, the reversibility of this reaction was observed at day 7 after the substance treatment. In addition the score for erythema and oedema formation did not meet the criteria of any category for skin corrosion/irritation under CLP.

Based on the study results, it is concluded that the substance was not irritating to the skin of the rabbits.