Lauroyl chloride

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 is comparable to OECD Guideline 405 with acceptable restrictions (partly limited documentation; 50 μl instead of 100 μl test substance instilled. Study sufficient for evaluation of this endpoint.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1968

Report date:

1968

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

application volume less than recomended(50µL)

Principles of method if other than guideline:

Before OECD Guideline 405 was established, eye irritation was tested using an internal method (BASF test). White Vienna rabbits were used. Usually 50 µl or mg of the test substance were applied to the conjunctival sac of one eye of 2 animals. The saline-treated adjacent eye served as a control.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Lauroyl chloride

EC Number:

203-941-7

EC Name:

Lauroyl chloride

Cas Number:

112-16-3

Molecular formula:

C12H23ClO

IUPAC Name:

dodecanoyl chloride

Constituent 2

Reference substance name:

XVIII/195

IUPAC Name:

XVIII/195

Details on test material:

- Name of test material (as cited in study report): Laurylsaeurechlorid
- Physical state: liquid
- Purity: no data
- Expiration date of the lot/batch: not reported
- Stability under test conditions: not reported
- Storage condition of test material: not reported

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Breeder
- Weight at study initiation: 2.00 and 3.57 kg

ENVIRONMENTAL CONDITIONS
not reported

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: one drop of saline into the other eye

Amount / concentration applied:

50 µl

Duration of treatment / exposure:

Treatment was once. The eye was left unwashed.

Observation period (in vivo):

8 days

Number of animals or in vitro replicates:

2

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24 - 48 - 72 hh

Score:

0

Max. score:

0

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24 - 48 - 72h

Score:

0

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24 - 48 - 72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 6 d

Remarks on result:

other: see table for further details

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24 - 48 -72 h

Score:

0

Any other information on results incl. tables

Descriptive scores of the raw data have been converted to Draize numerical scores.

Animal	Reading	Opacity	Iritis	Redness	Chemosis	Comment
1	1 h	0	0	2	0
2	1 h	0	0	1	0
1	3 h	0	0	2	0
2	3 h	0	0	1	0
1	24 h	0	0	1	0
2	24 h	0	0	1	0
1	48 h	0	0	1	0
2	48 h	0	0	1	0
1	72 h	0	0	1	0
2	72 h	0	0	1	0
1	6 d	0	0	0	0	Cornea checked with fluorescein
2	6 d	0	0	0	0	Cornea checked with fluorescein
1	8 d	0	0	0	0	Cornea checked with fluorescein
2	8 d	0	0	0	0	Cornea checked with fluorescein
mean	24 - 48 h	0.00	0.00	1.00	0.00

Applicant's summary and conclusion

Executive summary:

The study is comparable to OECD Guideline 405 with acceptable restrictions (limited documentation, reduced application volume). The study is however sufficient for evaluation of this endpoint. Conjunctivae redness was slight and reversible within 5 d. No other effect was noted.

In conclusion, Lauroylchloride is non-irritating to the eyes. (no classification according to EU or GHS)