Registration Dossier

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-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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:
There were no signs of systemic reaction to treatment.
Body weight:
Slightly low bodyweight gains were recorded for two males and one female on Day 8; these animals achieved anticipated gains on Day 15. All other rats achieved anticipated bodyweight gains throughout the study.
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.