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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study is comparable to OECD Guideline 404 with acceptable restrictions (unusual application; only 0.2 ml applied [but lethal effects expected after recommended amount]; exposure period 2 h; no reading 1 h after exposure period; no data on edema; in the result section data given only 24 and 72 h after application).

Data source

Reference
Reference Type:
publication
Title:
Tissue reactions to 2-chloroethanol in rabbits
Author:
Guess WL
Year:
1970
Bibliographic source:
Toxicol Appl Pharmacol 16: 382-390

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Source: J.T. Baker Company
Purity verified by infrared analysis and index of refraction
No further data

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Purina lab chow and water ad libitum
no further data

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
physiological saline
Controls:
yes, concurrent vehicle
Amount / concentration applied:
1, 10, 20, 100%; 0.2 ml applied
Duration of treatment / exposure:
2 h
Observation period:
72 h
Number of animals:
6 per concentration
Details on study design:
Glas wells (inner diameter 1 cm) sealed to the skin; test solution added and closed by a coverslip.
Scoring according to Draize (1944) 24, 48, and 72 h after application.

Results and discussion

In vivo

Results
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 h
Score:
0.6
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritant / corrosive response data:
Only the pure material caused a slight transient erythema to the intact skin; no effects with dilutions or control. No data were presented after 48 h. Data on edema were not given, however, edema is not presumed.
Other effects:
No data were given on systemic effects although a dose of 240 mg/animal should induce such effects.

Any other information on results incl. tables

Irritant effects on rabbit skin after dermal application of 0.2 ml pure test substance

Scoring of erythema according to Draize (1944), means of 6 rabbits

Dilution

Post exposure time in intact skin

Post exposure time in abraded skin

24 h

72 h

24 h

72 h

Undiluted

0.6

0

1.0

1.0

20%

0

0

0.6

0.3

10%

0

0

0

0.3

1%

0

0

0.3

0.3

Applicant's summary and conclusion

Conclusions:
In rabbits only slight, transient erythema was reported after dermal application of 0.2 ml pure test substance to the intact skin.
Executive summary:

The study is similar to OECD Guideline 404 with acceptable restrictions (unusual application; only 0.2 ml applied; exposure period 2 h; no reading 1 h after exposure period; no data on edema; in the result section data given only 24 and 72 h after application).

Six New Zealand White rabbits per group were exposed to 0.2 ml test solution for 2 h. Pure test substance as well as dilutions of 1, 10, 20% were tested. Readings according to Draize were done 24, 48, and 72 h after application. Slight erythema was reported after 24 h using the pure test substance. The effect was reversible. No effects were detected after application of dilutions. Data on (expected) systemic effects were not documented.

Conclusion: In rabbits only slight, transient erythema was reported after dermal application of 0.2 ml pure test substance to the intact skin.