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Toxicological information

Acute Toxicity: dermal

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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

Referenceopen allclose all

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 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 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:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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 levelsopen allclose all
Sex:
not specified
Dose descriptor:
LD100
Effect level:
320 mg/kg bw
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.