2,3,3-trimethyl-3H-indole-5-carboxylic acid

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1988-09-13 to 1988-09-20

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

documentation insufficient for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted 12 May 1981

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,3,3-trimethyl-3H-indole-5-carboxylic acid

EC Number:

282-162-4

EC Name:

2,3,3-trimethyl-3H-indole-5-carboxylic acid

Cas Number:

84100-84-5

Molecular formula:

C12H13NO2

IUPAC Name:

2,3,3-trimethyl-3H-indole-5-carboxylic acid

Test material form:

other: Moist presscake, white-faint reddish

Specific details on test material used for the study:

- Other: beige color, pH approx. 4 (100 g/L H20)

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Interfauna UK Ltd.
- Weight at study initiation: 2.9-3.4 kg
- Housing: individual cages (type III) stored in separate section in animal room
- Diet (e.g. ad libitum): ssniff K 4; 1 x 100-120 g/animal/day
- Water (e.g. ad libitum): tap water (7 am to 7 pm)
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 2
- Humidity (%): approx. 50
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

yes, concurrent vehicle

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg of moisted test substance

VEHICLE
- Amount(s) applied (volume or weight with unit): only small amounts for humidification

NEGATIVE CONTROL
- Amount(s) applied (volume or weight): only small amounts of vehicle (water only)

Duration of treatment / exposure:

4 hrs

Observation period:

1, 24, 48, 72 hours as well as 7 day after end of exposure

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 6 x 6 cm
- Type of wrap if used: adhesive plaster (Hansamed - Wundpflaster Hypoallergen (Beiersdorf No. 2342)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes (water)
- Time after start of exposure: 4 hrs

OBSERVATION TIME POINTS
(indicate if minutes, hours or days) 1, 24, 28, 72 hours as well as 7 days after end of exposure

SCORING SYSTEM:
- Method of calculation: DRAIZE-grades

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

All animals had a score of 0.0 for both erythema and edema during the entire observation period.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Trimethylcarbonsäure was not irritating in the in vivo skin irritation test under the experimental conditions described in this report.

Executive summary:

In a primary dermal irritation study performed in accordance with OECD Guideline 404 (Acute Dermal Irritation / Corrosion), adopted 12 May 1981, adult male albino rabbits (strain New Zealand White) were dermally exposed to 500 mg of humidified Trimethylcarbonsäure (vehicle: water) for 4 hours to 36 cm² body surface area.  Animals then were observed for 7 days.  Irritation was scored by the method of DRAIZE.

No irritation occurred during the observation period (DRAIZE grade 0 in all animals).

In this study, Trimethylcarbonsäure is not a dermal irritant.