3-chloropropene

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: - non-standard, non GLP - limited information on methods, low number of animals

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1958

Report date:

1958

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

A total of 6 rabbits (2 per dose group) were treated for 24h with 3-chloropropene dissolved in dipropyleneglycol monomethylester under occlusive conditions.

GLP compliance:

no

Test type:

standard acute method

Limit test:

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): allul chloride
- no further information given

Test animals

Species:

rabbit

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

no data

Administration / exposure

Type of coverage:

occlusive

Vehicle:

other: dipropyleneglycol monomethylester

Details on dermal exposure:

TEST SITE
- Area of exposure: stomach
- % coverage: no data
- Type of wrap if used: occlusive, rubber cuff

REMOVAL OF TEST SUBSTANCE
- no data

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1, 0.2 and 0.398 g/Kg = 100, 200 and 398 mg/kg bw
- Concentration (if solution): 20 % (v/v)
- Constant volume or concentration used: no

Duration of exposure:

24 h

Doses:

100, 200 and 398 g/kg bw

No. of animals per sex per dose:

2

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: pretreatment, on treatment day and weekly thereafter
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:

Statistics:

no statistics conducted

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

398 mg/kg bw

Based on:

test mat.

Remarks on result:

other: rough estimate, as at this dose 1 of 2 animals died while all animals at lower doses survived

Mortality:

100 mg/kg bw: 0/2
200 mg/Kg bw: 0/2
398 mg/Kg bw: 1/2

Clinical signs:

other: - survivors: scab formation is reported 8 and 15 d post treatment, no further information available - dead animal (high dose, observed 6 times on the day of exposure due to intensive reaction, timepoints not precisely reported): first observation: slight

Gross pathology:

not conducted

Other findings:

no data

Any other information on results incl. tables

Table 1: animal assignment and body weight development

	Low dose		Mid dose		High dose
Dose (mg/kg bw)	100	100	200	200	398	398
Cage No.	1817	1818	1819	1820	1811	1812
Animal No. and sex	427 male	507 female	481 female	276 male	363 male	364 male
Weight (kg) at d 0	2.27	2.50	2.43	2.68	2.95	2.98
Weight (kg) at d 1	2.22	2.41	2.49	2.74	2.85	2.99
Weight (kg) at d 8	2.50	2.72	2.57	2.70	Death at d 3	2.96
Weight (kg) at d 15	2.60	2.96	2.83	2.81		3.13

d 0 is the date of the start of the treatment

Applicant's summary and conclusion

Interpretation of results:

Toxicity Category III

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

A total of 6 rabbits (2 per dose group) were treated for 24h with 3-chloropropene dissolved in dipropyleneglycol monomethylester under occlusive conditions on the clipped skin with doses of 100, 200 and 398 mg/Kg in a non-guideline study.
1 of 2 animals died in the high dose group 2 days after the end of treatment probably due to severe skin burns and cyanosis. Based on this finding the high dose of 398 mg/Kg can be regarded as a rough estimate of a dermal LD 50 in the rabbit.

Executive summary:

In the present study (Dow K-1720-4A 1958) a total of 6 rabbits (2 per dose group) were treated for 24h with 3-chloropropene dissolved in dipropyleneglycol monomethylester under occlusive conditions on the clipped skin with doses of 100, 200 and 398 mg/Kg in a non-guideline study.

Animals were treated with the test item and subsequently observed for clinical signs. 1 of 2 animals of the high dose group showed signs of skin burns after teatment that were checked 6 times on the first day after exposure. This animal died 2 days after the end of treatment probably due to severe skin burns and cyanosis. For the other animals of the high and the mid dose scab formation after 8 and 15 days are reported.

Based on this finding the high dose of 398 mg/Kg can be regarded as a rough estimate of a dermal LD 50 in the rabbit.

The information available is limited therefore a reliability score of Klimisch 4 was assinged.

The determined LD50 of 398 mg/Kg bw triggers for 3 -chloropropene a classification as Category III (Danger, toxic in contact with skin) according to CLP as implementation of UN GHS in the EU (REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL).