COASOL 290 PLUS

Repeated dose toxicity: dermal

Administrative data

Endpoint:

short-term repeated dose toxicity: dermal

Type of information:

read-across based on grouping of substances (category approach)

Adequacy of study:

supporting study

Study period:

1951

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

documentation insufficient for assessment

Justification for type of information:

See attached document with the justification for the category/read-across approach.

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:

1951

Report date:

1951

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

equivalent or similar to OECD TG 410 with deficiencies

GLP compliance:

no

Remarks:

study conducted prior to GLP

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

n-butyl adipate

IUPAC Name:

n-butyl adipate

Details on test material:

- Name of test material (as cited in study report): n-butyl adipate
- Lot/batch No.: #216-RD-69 (quantity - 1 gallon) and #217-RD-31 (quantity - half gallon)
- Source - Carbide and Carbon Chemicals Division of U.C.C.
- Other: Emulsifier 75H14S was chosen as a dispersant

Test animals

Species:

rabbit

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

no information available

Administration / exposure

Type of coverage:

other: assumed to be open - the liquid was massaged into the skin of animals for 1 minute at an interval of every 15 minutes for 1 hour

Vehicle:

unchanged (no vehicle)

Details on exposure:

5 dermal applications were made per week with undiluted n-butyl adipate at doses of 0.5 and 1 ml/kg for 30 inunctions to an area of approximately 100 cm2. The liquid was massaged into the skin of animals for 1 minute at an interval of every 15 minutes for 1 hour. At the end of the day, the skin of each rabbit was blotted with cleansing tissue to remove any excess.

Analytical verification of doses or concentrations:

no

Details on analytical verification of doses or concentrations:

not applicable

Duration of treatment / exposure:

30 inunctions (5 dermal applications/week)

Frequency of treatment:

30 inunctions (5 dermal applications/week)

Doses / concentrations

Doses / concentrations 1

Remarks:

Doses / Concentrations:
0.5
Basis:
other: ml/kg

Doses / concentrations 2

Remarks:

Doses / Concentrations:
1.0
Basis:
other: ml/kg

No. of animals per sex per dose:

10 rabbits/dose (sex unspecified)

Control animals:

yes

Details on study design:

no information available

Positive control:

not applicable

Examinations

Observations and examinations performed and frequency:

CAGE SIDE OBSERVATIONS: No data
DETAILED CLINICAL OBSERVATIONS: No data
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
FOOD CONSUMPTION: No
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: No
CLINICAL CHEMISTRY: No
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No

Sacrifice and pathology:

GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes

Other examinations:

none

Statistics:

no information available

Results and discussion

Results of examinations

Clinical signs:

no effects observed

Dermal irritation:

not examined

Mortality:

no mortality observed

Body weight and weight changes:

effects observed, treatment-related

Food consumption and compound intake (if feeding study):

not examined

Food efficiency:

not examined

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

not examined

Ophthalmological findings:

not examined

Haematological findings:

not examined

Clinical biochemistry findings:

not examined

Urinalysis findings:

not examined

Behaviour (functional findings):

not examined

Organ weight findings including organ / body weight ratios:

not examined

Gross pathological findings:

no effects observed

Histopathological findings: non-neoplastic:

no effects observed

Histopathological findings: neoplastic:

no effects observed

Details on results:

CLINICAL SIGNS AND MORTALITY - no treatment related mortality was noted
BODY WEIGHT AND WEIGHT GAIN - Statistically significant decreases were noted in the body weight of the surviving animals of the 1.0 ml/kg group
FOOD CONSUMPTION - no information available
OPHTHALMOSCOPIC EXAMINATION - no information available
HAEMATOLOGY - no information available
CLINICAL CHEMISTRY - no information available
URINALYSIS - no information available
NEUROBEHAVIOUR - no information available
ORGAN WEIGHTS - no information available
GROSS PATHOLOGY - Pathological changes unrelated to treatment with n-butyl adipate were noted in thos animals found dead from the treatment groups, while no treatment related changes were noted in the animals euthanased at the nd of the treatment period.
HISTOPATHOLOGY: NON-NEOPLASTIC - No changes attributable to exposure to n-butyl adipate

Effect levels

Dose descriptor:

NOAEL

Remarks on result:

not determinable

Remarks:

no NOAEL identified

Target system / organ toxicity

Critical effects observed:

not specified

Any other information on results incl. tables

None

Applicant's summary and conclusion

Conclusions:

Based on the observations noted in this study, it appears that 30 repeated 5 day/week applications of 0.5 ml/kg of undiluted n-butyl adipate to rabbits did not reveal significant effects.