1-[(2-tert-butylcyclohexyl)oxy]butan-2-ol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 1991-11-19 to 1991-12-13

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Version / remarks:

EEC Directive 84/449/EEC, Annex V, Method B3.

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Details on test material:

- Name of test material (as cited in study report): 1-(2-tert-Butyl cyclohexyloxy)-2-butanol, cited as P-#620 in the report

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS: Sprague-Dawley origin Crl. CD (SD) BR VAF Plus
- Source: Charles River U.K. Limited, Margate, Kent, England
- Age at study initiation: 7 to 10 weeks of age
- Weight at study initiation: 220 to 281 g
- Housing: individually in metal cages with wire mesh floors
- Diet (e.g. ad libitum): standard laboratory diet (Biosure LAD 1) ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 9 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22 °C
- Humidity (%): mean 58%
- Air changes (per hr): 10 to 15 changes per hour
- Photoperiod: 12 hrs dark / 12 hours light

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: approx. 10% of the total body surface, dorso-lumbar region
- Type of wrap if used: gauze held in place with an impermeable dressing encircled firmly around the trunk

REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm water (30-40°C)
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.14 mL/kg bw (specific gravity 0.935)

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 animals/sex/dose

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality: twice daily
Bodyweight: on days 1 (prior to dosing), 8 and 15.
Clinical signs: soon after dosing and at frequent intervals for the remainder of Day 1 (a period of 5 hours). Thereafter daily until day 14.
- Necropsy of survivors performed: yes
- Other examinations performed:
Macroscopic examination which consisted of opening the abdominal and thoracic cavities.
Dermal responses: eythema, eschar and oedema formation

Statistics:

none

Results and discussion

Preliminary study:

not applicable

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

no mortality

Clinical signs:

other: There were no signs of systemic reaction to treatment.

Gross pathology:

No macroscopic abnormalities were observed for animals killed on Day 15.

Other findings:

Sites of application showed no irritation or other dermal changes (scores of zero for erythema and oedema were recorded for all animals)

Any other information on results incl. tables

No other information

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Dermal LD50Combined > 2000 mg/kg bw

Executive summary:

In a limit acute dermal toxicity study performed according to the E.U method B.3 and in compliance with GLP, groups of young adult Sprague-Dawley rats (5/sex) were occlusively exposed to undiluted P-#620 (89.01 % a.i) for 24 hours to 10% of the body surface at dose of 2000 mg/kg bw (limit test). The animals were observed for mortality, clinical signs including dermal reactions and body weight for 14 days and then necropsied for macroscopic observations.

 

No mortality occurred during the study. There were no signs of systemic reaction to treatment. Sites of application showed no irritation or other dermal changes.No abnormality was revealed at autopsy.

  

Dermal LD₅₀Combined > 2000 mg/kg bw

 

Under the test conditions, P-#620 is not classified according to the annex VI of the Regulation EC No. 1272/2008 (CLP) and of the Directive 67/548/EEC.