Alcohols, C12-13-branched and linear

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1998

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to the appropriate OECD guideline and in compliance with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Principles of method if other than guideline:

Method: other: An amount of 0.1 ml of test material was instilled in the conjunctival sac of the right eye. The upper and lower lids were then held together for 1 second. The left eye was untreated and served as the control.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Alcohols, C10-16

EC Number:

267-019-6

EC Name:

Alcohols, C10-16

Cas Number:

67762-41-8

IUPAC Name:

tetradecan-1-ol

Details on test material:

- Name of test material (as cited in study report): Safol(TM) 23 Alcohol C10-16 alcohols Type B (also known as Compound 33A). Equivalent to Alcohols, C12-13-branched and linear (CAS 740817-83-8).

- Physical state: clear transparent liquid

- Storage condition of test material: at ambient temperature

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: young adults
- Weight at study initiation:1870-2132g
- Housing: individually housed in stainless stel cages with perforated floor
- Diet: standard laboratory rabbit diet, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-3
- Humidity (%): 40-82.5
- Air changes (per hr): ca. 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1ml
- Concentration (if solution): undiluted

Duration of treatment / exposure:

single instillation, not washed

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

3M

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not rinsed

SCORING SYSTEM: According to guideline

TOOL USED TO ASSESS SCORE: not reported

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 24/48/72h

Score:

0

Max. score:

0

Irritant / corrosive response data:

All scores at 24/48/72 hours were 0 in all animals.
At 1 hour after treatment, slight redness of the  conjunctivae (grade 1 vessels definitely injected) was observed in all  animals.  At 24, 48, and 72 hours, no signs of eye irritation were  observed in any of the 3 animals. Fully reversible in the 72 hour observation period.

Other effects:

None reported.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Safol(TM) 23 Alcohol C10-16 alcohols Type B (also known as Compound 33A) is not an eye irritant according to EU or GHS criteria.