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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

Constituent 1
Chemical structure
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 / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
100 mg/kg bw/day
Basis:
nominal per unit body weight
Remarks:
Doses / Concentrations:
300 mg/kg bw/day
Basis:
nominal per unit body weight
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).

 

 

 

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