2-chloroethanol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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 with OECD Guideline 302 with acceptable restrictions (partly limited documentation, e.g. no details about test animals; no data on clinical signs or necropsy).

Data source

Reference

Reference 1

Reference Type:

publication

Title:

2-Chloroethanol - Percutaneous toxicity of a solvent

Author:

Wahlberg JE & Boman A

Year:

1978

Bibliographic source:

Dermatologica 156: 299-302

Reference 2

Reference Type:

publication

Title:

Comparative percutaneous toxicity of ten industrial solvents in the guinea pig

Author:

Wahlberg JE and Boman A

Year:

1979

Bibliographic source:

Scand J Work Environ Health 5: 345-351

Reference 3

Reference Type:

publication

Title:

Acute percutaneous toxicity of organic solvents in the guinea pig

Author:

Boman A & Wahlberg JE

Year:

1981

Bibliographic source:

CURRENT EXPERIMENTAL STUDIES ON ORGANIC SOLVENTS; SYMPOSIUM APRIL 27, 1981; Solna, Sweden; page 5

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-chloroethanol

EC Number:

203-459-7

EC Name:

2-chloroethanol

Cas Number:

107-07-3

Molecular formula:

C2H5ClO

IUPAC Name:

2-chloroethan-1-ol

Details on test material:

Source: Union Carbide, USA
Purity 98-100%

Test animals

Species:

guinea pig

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

initial weight 370-375 g; no further details

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

Application site (3 cm²) closed to exclude inhalation and licking; 0.7% of the body area was exposed.
No further data

Duration of exposure:

Single application, no data about washing.

Doses:

0, 25, 63, 88, 100, 125, 250, 2000 µl/animals; mean body weight was given (see Table below)

No. of animals per sex per dose:

Details see Table below

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days (also data after 3 and 5 weeks were documented)
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: no

Statistics:

LD50 was not calculated by the authors (graphical estimation performed)

Results and discussion

Effect levels

Effect levels 1

Sex:

not specified

Dose descriptor:

LD100

Effect level:

320 mg/kg bw

Effect levels 2

Sex:

not specified

Dose descriptor:

LD50

Effect level:

260 mg/kg bw

Remarks on result:

other: graphical estimation from reported data

Mortality:

Data are presented in the Table below

Clinical signs:

no data

Body weight:

At 25 µl/animal slight decrease in body weight gain but statistically not significant. No further data.

Gross pathology:

No data

Other findings:

No

Any other information on results incl. tables

Acute toxicity in guinea pigs after dermal exposure to different dose levels

Test substance solved in distilled water

Volume (µl/GP) applied	Concen-tration in water	Dose in µl ts/GP	Mean weight GP (g)	Dose in mg/kg bw *	Cumulative mortality after days#
					1	2	3	4	14
2000	Pure	2000	372	6450	20/20	20/20	20/20	20/20	20/20
250	Pure	250	373	800	20/20	20/20	20/20	20/20	20/20
100	Pure	100	374	320	20/20	20/20	20/20	20/20	20/20
250	50%	125	372	400	5/5	5/5	5/5	5/5	5/5
250	35%	88	375	280	6/20	7/20	8/20	11/20	11/20
250	25%	63	373	200	0/20	0/20	0/20	0/20	1/20
250	10%	25	374	80	0/10	0/10	0/10	0/10	0/10
2000	0%	0	370	0	0/20	0/20	0/20	0/20	0/20

GP: guinea pig; ts: pure test substance; *: not reported by the authors, additional calculation; #: number of dead animals per treated animals

Applicant's summary and conclusion

Conclusions:

In acute dermal toxicity studies in guinea pigs a LD50 value of 260 mg/kg bw could be estimated.

Executive summary:

The study is comparable with OECD Guideline 302 with acceptable restrictions (partly limited documentation, e.g. no details about test animals; no data on clinical signs or necropsy).

Five to 20 guinea pigs per dose level received dermal application of 80 -6450 mg/kg bw (7 dose groups). Pure test substance (high dose levels) or dilutions in water were applied. The post exposure observation period was 14 days. At 320 mg/kg bw 20 out of 20 animals died the 1st day after application. Graphical estimation resulted in a LD50 of 260 mg/kg bw.

Conclusion: In acute dermal toxicity studies in guinea pigs a LD50 value of 260 mg/kg bw could be estimated.