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

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 1988-08-04 to 1988-08-11

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: 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 405 (Acute Eye Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye 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
- Lot/batch No.: DC 1295.3
- Stability under test conditions: Stable

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH 4414 Fuellinsdorf / Switzerland
- Age at study initiation: males (14 weeks); females (15 weeks)
- Weight at study initiation: males (2.8 - 2.9 kg); females (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

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.1 ml per animal

Duration of treatment / exposure:

No data

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

2 males and 1 females

Details on study design:

The test article (0.1 ml per animal) was placed in the conjunctival sac of the left eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of the test article. The right eye remained untreated and served as the reference control.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: Average score: 0

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

other: Average score: 0

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

other: Average score: 0

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: Average score: 0

Results 5

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

13

Remarks on result:

other: Average score: 0

Any other information on results incl. tables

Eye irritation scores: Time Animal Sex Cornea opacity Iris Conjunctivae Cumul.Score Mean Cumul. Score Redn. Chem. 1HR 27 M 0 0 1 0 1 1.33 28 M 0 0 1 1 2 29 F 0 0 1 0 1 24HRS 27 M 0 0 0 0 0 0 28 M 0 0 0 0 0 29 F 0 0 0 0 0 48HRS 27 M 0 0 0 0 0 0 28 M 0 0 0 0 0 29 F 0 0 0 0 0 72HRS 27 M 0 0 0 0 0 0 28 M 0 0 0 0 0 29 F 0 0 0 0 0 Results: Toxic symptoms / Mortality No acute toxic symptoms were observed in the animals during the test period, and no mortality occurred. Irritation Alkyl (C13-C15) glycidylether showed a primary irritation score of 0.33, when applied undiluted to the rabbit eye mucosa. Coloration No corrosion of the cornea was observed at any of the measuring intervals. Body weights The body weight gain of all rabbits was similar. Necropsy No necropsy was performed. All animals were killed and discarded.

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 0.1 ml Alkyl (C13-C15)-glycidylether was not irritating to the rabbit eyes.

Executive summary:

This study was conducted according to OECD guideline and EU method in order to evaluate the risk potential of Alkyl (C13-C15)–glycidylether to the eyes. 2 male and 1 female rabbits were used in the study. 0.1 ml of the substance was placed in the conjunctiva sac of the left eye of each rabbit and the right eye served as control. Then the eyes were washed after 24 hours. The examination results showed that only slight erythema was observed in the three rabbits after 1h and no abnormalities were observed after 24h, 48h and 72h. The results indicated that the substance was not irritating to the eyes of rabbits.