2-hydroxybenzoic acid 2-butyloctyl ester

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

20 February 1998 to 19 August 1998

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

dated February 24, 1987

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

431-090-3

EC Name:

-

Cas Number:

190085-41-7

Molecular formula:

C19 H30 O3

IUPAC Name:

2-butyloctyl 2-hydroxybenzoate

Test animals

Species:

rat

Strain:

other: Cr1:CD(SD)BR

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Kingston, New York 12484 (USA)
- Age at study initiation: young adults at least 9-12 weeks old
- Weight at study initiation: males, 275-315 g; females, 214-221 g
- Fasting period before study: none
- Housing: group housed (6/cage) during acclimation; individually in suspended stainless steel cages with wire mesh bottoms during the study
- Diet (ad libitum): Certified Rodent Diet No. 5002 (PMI Nutrition International, St. Louis, Missouri, USA)
- Water (ad libitum): municipal water supply (Elizabethtown Water Company, Westfield, New Jersey, USA).
- Acclimation period: 9 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-24
- Humidity (%): 28-62
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12 (automated timer)


IN-LIFE DATES: From: 26 February 1998 To: 12 March 1998

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Preparation of animals:

Approximately 24 hours before dosing, the hair of each rat was closely clipped from the trunk (dorsal surface area and sides from scapular to pelvic areas) with an electric clipper exposing at least 10% of the body surface area (approximately 6 cm x 6 cm). The skin was not abraded.

Administration:

Applied to the clipped skin of the dorsal trunk surface. Doses were calculated using pretest (Day 1) body weights. The material was applied directly onto the exposed skin of the animal and spread evenly over the entire area. A layer of 8-ply gauze was then placed over the application site. The gauze was then covered with impervious plastic and secured with an Elastoplast bandage. Following approximately 24 hours, the wrappings were removed and the site wiped free of excess test material with gauze moistened with 0.9% saline.

Duration of exposure:

approximately 24 hours

Doses:

A single dose level, 2000 mg/kg bwt

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

Duration of study:

A single dose was administered to each animal, followed by 14 days of observations.

Observations:

Observations for mortality were made twice daily. Each animal was removed from its cage and observations of general condition, skin and fur, eyes, nose, oral cavity, abdomen and external genitalia as well as evaluations of respiration and palpation for tissue masses were made. All abnormalities, including severe dermal effects, were recorded.

Evaluation of dermal irritation:

Dermal irritation was scored (Table 1) approximately 60 minutes, 24, 48, and 72 hours after bandage removal and daily thereafter. At each interval, treatment sites were evaluated for erythema and edema and other evidence of dermal irritation. Special notation was made of tissue damage, eschar, other evidence of irreversible alteration of tissue structure, and any other dermal abnormalities.

Body weights:

These were obtained on Day 0 (at time of clipping), on Day 1 (just before dosing) and on Days 8 and 15.

Food consumption:

Each animal’s quantity of feed was visually inspected, and any qualitative decreases in food consumption, relative to other animals on test, were recorded.

Postmortem:

At study termination (Day 15), all animals were euthanatized by exsanguination following carbon dioxide anesthesia. Necropsy included macroscopic examinations of all external surfaces and orifices, the organs and tissues of the cranial, thoracic, abdominal and pelvic cavities and neck and remainder of the carcass. All abnormalities were recorded and any tissues with lesions were saved.

Statistics:

Based on the study results, calculation of an LD50 value was not applicable.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

There was no mortality reported.

Clinical signs:

other: Six of the ten animals exhibited slight red stains on the snout on the day of dosing. All animals were free of clinical signs by Day 2. The test material did not cause dermal irritation with no irritation scores other than 0 reported during the study.

Gross pathology:

A single animal at necropsy exhibited slightly firm, slightly white discolored lungs. All other animals were free of macroscopic abnormalities.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this study, the dermal LD50 of Hallbrite BHB in rats is greater than 2000 mg/kg bwt.