Alkenes, C13-14, hydroformylation products, low boiling

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was conduceted according to a protocol that is equivalent to current guideline. It was not compliant with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Dodecan-1-ol

EC Number:

203-982-0

EC Name:

Dodecan-1-ol

Cas Number:

112-53-8

IUPAC Name:

dodecan-1-ol

Details on test material:

- Name of test material (as cited in study report): Alfol 12 alcohol

- Other: Sample No. 8429H, 10-24-74

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS

- Housing: individually housed in metal cages elevated above the droppings

- Diet: Purina rabbit chow, ad libitum

- Water: tap water, ad libitum

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye

Amount / concentration applied:

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

Duration of treatment / exposure:

24 hours (single instillation, not washed)

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

6

Details on study design:

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

Results and discussion

In vivo

Results

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Time point:

other: 24 hours

Score:

26.7

Max. score:

20

Irritant / corrosive response data:

Mild to moderate erythema of the palpebral and bulbar conjunctivae , mild to moderate chemosis, mild mucoid discharge and a mild to moderate corneal opacity involving one-fourth to three-fourths of the corneal surface. By 72 hours, all test eyes showed improvement in the parameters of irritation in all but one animal. That one animal became worse and even developed mild iritis.

Any other information on results incl. tables

Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility	Cornea	Iris	Conjunctivae
60 min	0/0/0/0/0/0	0/0/0/0/0/0	4/6/4/6/6/4
24 h	5/30/30/20/5/20	0/0/0/0/0/0	4/10/10/10/8/8
48 h	0/30/10/10/0/20	0/0/0/0/0/0	4/10/10/10/4/8
72 h	0/40/5/5/0/5	0/5/0/0/0/0	2/14/4/8/2/4
Average 24h, 48h, 72h	13.05	0.3	7.2

 

 

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: FHSA

Conclusions:

The data suggests that if interpreted in terms of EU criteria, the test substance would be a category 2 eye irritant.