TCA

Repeated dose toxicity: dermal

Administrative data

Endpoint:

short-term repeated dose toxicity: dermal

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

August-October 1973.

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Experimental design: according to HAZARDOUS Substances, Part 191, Section 11, FDA, Washington 1965. No GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1974

Materials and methods

Principles of method if other than guideline:

Experimental design: according to HAZARDOUS Substances, Part 191, Section 11, FDA, Washington 1965.

Three level doses were applied to to a skin area of15 x 16cm in six rabbits (3 males and 3 females). After an exposure period of 8 hours, the test substance was washed with warm water. This was daily repeated for 5 days. During an observation period of 14 days, skin reaction (as described by Draize), general behavior, food consumption and body weight were daily observed. During the assay period, environmental conditions remained constant (Temperature: 21±2 °C, Humidity: 60± 3% and Photoperiod: twelve hours light and twelve hours darkness).

GLP compliance:

no

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

TCA

EC Number:

211-479-2

EC Name:

TCA

Cas Number:

650-51-1

Molecular formula:

C2HCl3O2.Na

IUPAC Name:

trichloroacetic acid

Details on test material:

- Name of test material (as cited in study report): NaTA

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Own breeding
- Weight at study initiation: 2.3-2.8 kg
- Housing: Animasl were individually housed in V2A cages (floor area 0.4 m2)
- Diet (e.g. ad libitum): ALTROMIN 2023 (Fa. ALTROMlN GmbH, Lage/Lippe); ad libitum, except on the day of treatment.
- Water (e.g. ad libitum): Ad libitum.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2 ºC
- Humidity (%): 60 ± 3 %
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: August-October 1973.

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

other: methyl-hydroxyethyl cellulose aqueous gel MH 300 P.

Details on exposure:

TEST SITE
- Area of exposure: between the anterior and posterior limbs of the animals.
- % coverage: 1/10 body surface, 15 x 16 cm
- Type of wrap if used: a 4-fold gauze and secured with a cuff
- Time intervals for shavings or clipplings: 3 days before the test

REMOVAL OF TEST SUBSTANCE
- Washing (if done): With warm water (30 ºC)
- Time after start of exposure: 8 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1 g/kg bw
- Concentration (if solution): 100, 300 and 900 mg/kg bw

VEHICLE
- Concentration (if solution): 1%

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

Exposure period: 8 hours
Duration of treatment: 5 days
Observation period: 14 days

Frequency of treatment:

Once a day

Doses / concentrations

Doses / concentrations 1

Remarks:

Doses / Concentrations:
100 mg/kg bw/day
Basis:
nominal per unit body weight

Doses / concentrations 2

Remarks:

Doses / Concentrations:
300 mg/kg bw/day
Basis:
nominal per unit body weight

Doses / concentrations 3

Remarks:

Doses / Concentrations:
900 mg/kg bw/day
Basis:
nominal per unit body weight

No. of animals per sex per dose:

3 male and 3 female rabbits per dose

Control animals:

no

Positive control:

No data

Examinations

Observations and examinations performed and frequency:

Skin reaction (as described by Draize), general behavior, food consumption and body weight were daily observed throughout the test period.

Sacrifice and pathology:

GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes

Results and discussion

Results of examinations

Clinical signs:

no effects observed

Dermal irritation:

no effects observed

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 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):

no effects observed

Organ weight findings including organ / body weight ratios:

no effects observed

Gross pathological findings:

no effects observed

Histopathological findings: non-neoplastic:

no effects observed

Histopathological findings: neoplastic:

no effects observed

Details on results:

No toxic effects were observed in any treated animal.

Effect levels

Dose descriptor:

NOAEL

Effect level:

>= 900 mg/kg bw/day (nominal)

Sex:

male/female

Basis for effect level:

other: overall effects

Target system / organ toxicity

Critical effects observed:

not specified

Any other information on results incl. tables

The NOAEL was greater or equal than 900 mg/kg bw/day.

Applicant's summary and conclusion

Conclusions:

The NOAEL was greater or equal than 900 mg/kg bw/day.

Executive summary:

This study has been carried out with the aim of evaluating the possible dermal toxicity in a repeated dose test of sodium trichloroacetate on the skin, usingNew Zealandrabbits (males and females). The experimental design complies with HAZARDOUS SUBSTANCES, Part 191, Section 11, FDA, Washington 1965. Three level doses were applied to to a skin area of15 x 16cm in six rabbits (3 males and 3 females). After an exposure period of 8 hours, the test substance was washed with warm water. This was daily repeated for 5 days. During an observation period of 14 days, skin reaction (as described by Draize), general behavior, food consumption and body weight were daily observed. During the assay period, environmental conditions remained constant (Temperature: 21±2 °C, Humidity: 60± 3% and Photoperiod: twelve hours light and twelve hours darkness). No toxic effects were observed in any treated animal. The NOAEL was greater or equal than 900 mg/kg bw/day (nominal).