2-chlorobutane

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well documented, according to accepted guidelines

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 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

Collective housing up to a maximum of 5 animals per cage, relative humidity was 50-85%, temperature was 20 ± 2°C.

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sec-Butylchloride

IUPAC Name:

Sec-Butylchloride

Constituent 2

Reference substance name:

2_chlor-butan

IUPAC Name:

2_chlor-butan

Constituent 3

Reference substance name:

2-chlorobutane

EC Number:

201-151-7

EC Name:

2-chlorobutane

Cas Number:

78-86-4

Molecular formula:

C4H9Cl

IUPAC Name:

2-chlorobutane

Test material form:

other: colourless, clear liquid

Details on test material:

- Name of test material (as cited in study report): sec-butylchloride
- Physical state: liquid
- Analytical purity: not reported
- Storage condition of test material: Max. 5°C, in the dark

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Firma Charles River Wiga, Sandhofer Weg 7, 8714 Sulzfeld
- Age at study initiation: Not reported
- Weight at study initiation: m: 194-233 g, f: 155-220 g
- Fasting period before study: Not reported
- Housing: Collective housing up to a maximum of 5 animals per cage (Macrolon type III)
- Diet (e.g. ad libitum): Ssniff-R Alleindiat (ad libitum). Ssniff Spezialdiaten GmbH 4770 Soest/Westfalen.
- Water (e.g. ad libitum): Drinking water as for human consumption in drinking bottles (ad libitum)
- Acclimation period: at least 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 2°C
- Humidity (%): 50 - 85%
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): artificial lighting from 7am - 7pm (12/12)

Administration / exposure

Type of coverage:

occlusive

Vehicle:

other: Oleum arachidis

Details on dermal exposure:

Prior to study initiation, the animals were acclimated to laboratory conditions for at least 7 days. 24 h before treatment, the fur was removed with electric clippers from an area of roughly 5 x 10 cm on the back of each animal. The skin was subsequently examined for abrasions and animals with healthy, intact skin were then marked (in color) for individual identification. The test article was applied as a 20 % dilution in Oleum arachidis. The pH value was 6.6. A single dermal application of the test article was performed. The substance was held in contact with the skin with a porous gauze dressing and ElastoplastR (Beiersdorf). The exposure period was 24 h.

Duration of exposure:

Test article was applied for 24 hours

Doses:

2000 mg/kg

No. of animals per sex per dose:

5/sex/dose

Control animals:

not required

Details on study design:

In each animal a number of clinical-toxicological signs were evaluated according to a modified Irwin-Screening procedure. Any change from the normal condition was noted (increase or decrease) and the degree of severity of any clinical symptoms was assessed. The animals were examined at the following intervals after treatment: 20 min, 1, 2, 3, 6, and 24 h and thereafter once daily up to day 14. After patch removal, dermal irritation was evaluated once daily for 14 days according to a scheme based on Draize. The body weights of all animals were recorded immediately before treatment (day 0) and surviving animals were reweighed on days 7 and 14 (termination). Animals found dead or killed in extremis were immediately necropsied. The surviving animals were sacrificed by CO2 asphyxiation after 14 days and gross pathological examinations were subsequently performed.

EVALUATION OF SKIN REACTION
(based on Draize):

Erythema and Eschar Formation Value

No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar
formation (injuries in depth) 4

Maximum possible = 4

Oedema Formation Value

No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well defined
by definite raising) 2
Moderate oedema (raised approximately 1
millimetre) 3
Severe oedema (raised more than 1
millimetre and extending beyond area
of exposure) 4

Maximum possible = 4

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD0

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortality observed

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortality observed

Mortality:

No pre-terminal deaths occurred

Clinical signs:

other: No abnormal clinical signs were observed

Gross pathology:

Gross pathological examinations at 14 days p.a (terminal necropsy) revealed no test article-dependent findings.

Other findings:

No other findings

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute LD0 and LD50 (dermal, rat) in this experimentwere both found to be > 2000 mg/kg bw. No mortality was observed

Executive summary:

No abnormal clinical signs were observed. No signs of erythema and oedema were observed. No pre-terminal deaths occurred. All animals showed normal weight gains. Gross pathological examinations at 14 days p.a. (terminal necropsy) revealed no test article-dependent findings. The following LD50 values were determined at 24 h and 14 days: male and female >2000 mg/kg bw.

Thus the substance is not subject to classification according to CLP (Regulation (EC) No 1272/2008) or DSD (Directive 67/548/EEC) for acute dermal toxicity.