3-chloropropene

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

other: - scientifically sound study - limited reporting, non-GLP - no substance purity information

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

only two animals tested, only 0.0447 mL applied instead of 0.1 mL

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

3-chloropropene

EC Number:

203-457-6

EC Name:

3-chloropropene

Cas Number:

107-05-1

Molecular formula:

C3H5Cl

IUPAC Name:

3-chloroprop-1-ene

Details on test material:

- Name of test material (as cited in study report): Allylchlorid, BAS 480 F
- Physical state: not reported
- Analytical purity: not reported
- Impurities (identity and concentrations): not reported
- Composition of test material, percentage of components: not reported
- Purity test date: not reported
- Lot/batch No.: 23469-77BD
- Expiration date of the lot/batch: not reported
- Stability under test conditions: not reported, but expected to be stable

Test animals / tissue source

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

no data

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): ca. 42 mg = 0.0447 mL
- Concentration (if solution): 100 %

Duration of treatment / exposure:

treatment once without washout

Observation period (in vivo):

72 h

Number of animals or in vitro replicates:

2, one male, one female

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no


SCORING SYSTEM: Scoring system according to Kay and Calandra (Kay, J.H. & Calandra, J.C. (1962) Interpretation of eye irritation tests. J. Soc. Cosmet. Chem. 13, 281–289. )

Results and discussion

In vivo

Results

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

of both animals

Time point:

other: 1 h post treatment

Score:

1.5

Max. score:

2

Reversibility:

fully reversible within: 24 h

Remarks on result:

other: see table 1 for individual animal data

Irritant / corrosive response data:

A slight to moderate reddening of the conjunctiva 1 h after the treatment was the only sign of an adverse effect. The effect was fully reversible within the first 24 h after the treatment in both animals.

Other effects:

no

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	Cornea	Iris	Conjunctivae
	Opacity Max. score: 4	Area involved Max. score: 4	Max. score: 2	Redness Max. score: 3	Chemosis Max. score: 4	Discharge Max. score: 4
Animal 0083 (male)
60 min	0	0	0	1	0	0
24 h	0	0	0	0	0	0
48 h	0	0	0	0	0	0
72 h	0	0	0	0	0	0
Average 24h, 48h, 72h	0	0	0	0	0	0
Maximum average score (including area affected, max 110)	0	0	0	0	0	0
Reversibility*)	-	-	-	c	-	-
Average time (unit) for reversion	-	-	-	24 h	-	-
Animal 0086 (female)
60 min	0	0	0	0	0	0
24 h	0	0	0	0	0	0
48 h	0	0	0	0	0	0
72 h	0	0	0	0	0	0
Average 24h, 48h, 72h	0	0	0	0	0	0
Maximum average score (including area affected, max 110)	0	0	0	0	0	0
Reversibility*)	-	-	-	c	-	-
Average time (unit) for reversion	-	-	-	24 h	-	-

 

*) Reversibility: c. = completely reversible;= not completely reversible; n. = not reversible

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

3-Chloropropene was tested for its potency to cause eye irritation in an in vivo test in rabbits according to OECD 405 using 0.0447 mL of substance. The only effect noted was a slight to moderate reddening of the conjunctiva 1 h after the treatment in both animals that was fully reversible within 24 h. No other effects were reported. The applied amount is only 44,7 % of the amount stated in the guideline. As the effects reported are minimal and reversible within 24 h it can reasonably be assumed that even at a dose of 0.1 mL effects that would trigger a classification would not be seen. Based on these results the test item is not irritating to the eye in this test system and a classification for eye irritation according to CLP is not necessary.

Executive summary:

In the present study (BASF 1990) 3-Chloropropene was tested for its potency to cause eye irritation in an in vivo test in rabbits according to OECD 405 using 0.0447 mL of substance. The only effect noted was a slight to moderate reddening of the conjunctiva 1 h after the treatment in both animals that was fully reversible within 24 h. No other effects were reported. The applied amount is only 44.7 % of the amount stated in the guideline. As the effects reported are minimal and reversible within 24 h it can reasonably be assumed that even at a dose of 0.1 mL effects that would trigger a classification would not be seen. Based on these results the test item is not irritating to the eye in this test system and a classification for eye irritation according to CLP as implementation of UN GHS in the EU (REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL) is not necessary.

Animals were treated with 0.0477 mL (instilled into the right eye) of the undiluted test item. The treated eyes were not subsequentially rinsed. Irritating effects to the eye were scored at 60 min, 24, 48 and 72 h after the treatment according to the Score System by Kay and Calandra (Scoring system according to Kay and Calandra (Kay, J.H. & Calandra, J.C. (1962) Interpretation of eye irritation tests. J. Soc. Cosmet. Chem. 13, 281–289. ). As the initially developed slight to moderate reddening of the conjunctiva in both animals was fully reversible within 24 h the test was stopped 72 h after the start of treatment. Only two animals were treated, but as the effect is minimal and the results unequivocal, the test is judged to be reliable except for the uncertainty on substance purity.