2-(octylthio)ethanol

Repeated dose toxicity: dermal

Administrative data

Endpoint:

short-term repeated dose toxicity: dermal

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: According to secondary source listed below, the study was conducted with methods similar to OECD guidelines.

Data source

Reference

Reference 1

Reference Type:

secondary source

Title:

Prevention, Pesticides and Toxic Substances Reregistration Eligibility Decision (RED) Hydroxyethyl Octyl Sulfide

Author:

U.S. EPA

Year:

1995

Bibliographic source:

EPA 738-R-96-001

Reference 2

Reference Type:

study report

Title:

Unnamed

Year:

1994

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 410 (Repeated Dose Dermal Toxicity: 21/28-Day Study)

GLP compliance:

not specified

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Ethanol, 2-(octylthio)-

IUPAC Name:

Ethanol, 2-(octylthio)-

Constituent 2

Reference substance name:

2-(octylthio)ethanol

EC Number:

222-598-4

EC Name:

2-(octylthio)ethanol

Cas Number:

3547-33-9

Molecular formula:

C10H22OS

IUPAC Name:

2-(octylsulfanyl)ethan-1-ol

Constituent 3

Reference substance name:

Hydroxyethyl octyl sulfide

IUPAC Name:

Hydroxyethyl octyl sulfide

Details on test material:

- Name of test material (as cited in study report): hydroxyethyl octyl sulfide
- Substance type: Active
- Physical state: Liquid
- Analytical purity: 100 %

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

corn oil

Details on exposure:

Repeated dermal applications of technical in corn oil, 6 hours/day, 7 days/week for 21 days; the vehicle control group received corn oil only on the same regimen

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

21 days

Frequency of treatment:

6 hours/day, 7 days/week

Doses / concentrations

Remarks:

Doses / Concentrations:
50, 100 and 200 mg/kg
Basis:
nominal per unit body weight

No. of animals per sex per dose:

5

Control animals:

yes, concurrent vehicle

Details on study design:

No data

Positive control:

No

Examinations

Observations and examinations performed and frequency:

CAGE SIDE OBSERVATIONS: Yes
- Cage side observations included: mortality and clinical signs of toxicity


DERMAL IRRITATION (if dermal study): Yes



BODY WEIGHT: Yes


FOOD CONSUMPTION: yes


HAEMATOLOGY: Yes



CLINICAL CHEMISTRY: Yes



OTHER: organ weights

Sacrifice and pathology:

HISTOPATHOLOGY: Yes

Other examinations:

No data

Statistics:

No data

Results and discussion

Results of examinations

Clinical signs:

no effects observed

Dermal irritation:

effects observed, treatment-related

Mortality:

no mortality observed

Body weight and weight changes:

no effects observed

Food consumption and compound intake (if feeding study):

no effects observed

Food efficiency:

not specified

Water consumption and compound intake (if drinking water study):

not specified

Ophthalmological findings:

not specified

Haematological findings:

no effects observed

Clinical biochemistry findings:

no effects observed

Urinalysis findings:

not specified

Behaviour (functional findings):

not specified

Organ weight findings including organ / body weight ratios:

no effects observed

Gross pathological findings:

not specified

Histopathological findings: non-neoplastic:

no effects observed

Histopathological findings: neoplastic:

not specified

Details on results:

DERMAL IRRITATION: Treatment-related skin reactions were confined mainly to a proportion of animals receiving 100 or 200 mg/kg/day. Dermal reactions included: skin wrinkling in 1 male at 200 mg/kg/day; desquamation in 1 female at the vehicle control, 1 male and 1 female at 50 mg/kg/day, in 3 males and 2 females at 100 mg/kg/day, and in 5 males and 4 females at 200 mg/kg/day; and moderate to severe erythema usually in combination with moderate edema in 1 male and 1 female at the vehicle control and at 50 mg/kg/day, in 4 males and 0 females at 100 mg/kg/day, and in 4 males and 2 females at 200 mg/kg/day.

Effect levels

1

Dose descriptor:

NOEL

Effect level:

50 mg/kg bw/day (nominal)

Basis for effect level:

other: Dermal irritation

2

Dose descriptor:

LOEL

Effect level:

100 mg/kg bw/day (nominal)

Basis for effect level:

other: Dermal irritation

3

Dose descriptor:

NOEL

Effect level:

200 mg/kg bw/day (nominal)

Basis for effect level:

other: Systemic toxicity

Target system / organ toxicity

Critical effects observed:

not specified

Applicant's summary and conclusion

Conclusions:

Based on the results of the 21 day study, the NOEL for dermal irritation was 50 mg/kg/day and the LOEL was 100 mg/kg/day. For systemic toxicity, the NOEL was >200 mg/kg/day; a LOEL was not established.

Executive summary:

In a 21-day dermal toxicity study, New Zealand white rabbits (5/sex/dose) were given repeated dermal applications of technical hydroxyethyl octyl sulfide (100%) in corn oil at doses of 50, 100 or 200 mg/kg, 6 hours/day, 7 days/week for 21 days; the vehicle control group (5/sex) received corn oil only on the same regimen. Treatment had no adverse effect on survival, clinical signs, mean body weights, body weight gain, food consumption, hematology, clinical chemistry, organ weights or gross histopathology. Treatment-related skin reactions were confined mainly to a proportion of animals receiving 100 or 200 mg/kg/day. Dermal reactions included: skin wrinkling in 1 male at 200 mg/kg/day; desquamation in 1 female at the vehicle control, 1 male and 1 female at 50 mg/kg/day, in 3 males and 2 females at 100 mg/kg/day, and in 5 males and 4 females at 200 mg/kg/day; and moderate to severe erythema usually in combination with moderate edema in 1 male and 1 female at the vehicle control and at 50 mg/kg/day, in 4 males and 0 females at 100 mg/kg/day and in 4 males and 2 females at 200 mg/kg/day. Based on these results, for dermal irritation the NOEL was 50 mg/kg/day and the LOEL was 100 mg/kg/day. For systemic toxicity the NOEL was > 200 mg/kg/day; a LOEL was not established.