3-(chloromethyl)heptane

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: Comparable to guideline study with acceptable restrictions (pre-GLP; application volume 0.05 ml; only 2 animals were used; no wash-out of substance after 24 hours; examination using fluorescein)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1970

Report date:

1970

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Principles of method if other than guideline:

BASF-TEST: Before OECD guideline 405 was established, eye irritation was tested using an internal method. White Vienna rabbits were used. Usually approx. 50 µl of the test substance were applied to the conjunctival sac of one eye of 2 animals. The other, saline-treated eye served as control. The animals were observed several times on the treatment day and up to 8 days afterwards, and findings were recorded on working days. The eyes were not washed out after 24 h as specified in OECD Guideline 405.

GLP compliance:

no

Remarks:

GLP was not compulsory at the time the study was conducted

Test material

Test material information

Constituent 1

Reference substance name:

Ethylhexylchloride

IUPAC Name:

Ethylhexylchloride

Details on test material:

- Name of test material (as cited in study report): Ethylhexylchloride
- Physical state: liquid
- Purity: ca. 98%

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Gaukler
- Age at study initiation: young adult
- Weight at study initiation: animal 1: 2.08 kg; animal 2: 2.08 kg
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: sline-treated eye of same animal

Amount / concentration applied:

TEST MATERIAL
- Amount applied (volume): 0.05 ml
- Concentration: undiluted

Duration of treatment / exposure:

unspecified (substance was not washed out)

Observation period (in vivo):

8 days

Number of animals or in vitro replicates:

2 (males)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: no washing was done

READING TIME POINTS
10 min, 1 h, 3 h, 24 h, 48 h and 72 h after application

READING TIME POINTS USED FOR ASSESSMENT
24, 48 and 72 h

SCORING SYSTEM:
For the evaluation the BASF scores given in the raw data were converted to Draize scores

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24-48-72 hours

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other: applied volume 50 µl, short observation period (8 days)

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24-48-72 hours

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Remarks on result:

other: applied volume 50 µl, short observation period (8 days)

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24-48-72 hours

Score:

0

Max. score:

3

Reversibility:

other: not applicable

Remarks on result:

other: applied volume 50 µl, short observation period (8 days)

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24-48-72 hours

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other: applied volume 50 µl, short observation period (8 days)

Irritant / corrosive response data:

Both animals showed slight eye irritation during the first 3 hours that was fully reversible within 24 hours (see table below).

Other effects:

- Weight at study termination: animal 1: 2.25 kg; animal 2: 2.25 kg

Any other information on results incl. tables

Irritation scores:

Timepoint	Animal No.	Cornea		Iris	Conjunctivae
		Opacity	Area		Redness	Chemosis	Discharge
10 min	1	0	0	0	2	0	0
	2	0	0	0	2	0	0
1 h	1	0	0	0	1	0	0
	2	0	0	0	1	0	0
3 h	1	0	0	0	1	0	0
	2	0	0	0	1	0	0
24 h	1	0	0	0	0	0	0
	2	0	0	0	0	0	0
48 h	1	0	0	0	0	0	0
	2	0	0	0	0	0	0
72 h	1	0	0	0	0	0	0
	2	0	0	0	n.d.	0	0
Mean 24 - 48 - 72h		0	0	0	0	0	0

 n.d.: not determined

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information

Conclusions:

According to the results of this study the test substance is considered to be not irritating to the rabbit eye.