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

Endpoint summary

Description of key information

-skin irritation: not irritating; OECD 404 (12 May 1981); RL4; GLP; no effect in any animal (DRAIZE grade 0)

-eye irritation: not irritating; OECD 405 (24 Feb 1987); RL4; GLP; chemosis (DRAIZE grade 1) in one animal; fully reversible after 24 hours of application; no effect in any other animal.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted 12 May 1981

Deviations:

no

GLP compliance:

yes

Specific details on test material used for the study:

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

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

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

Irritation parameter:

erythema score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye 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

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted 24 February 1987

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Interfauna UK Ltd.
- Weight at study initiation: 2.9-3.1 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

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 µL (80 mg)

Duration of treatment / exposure:

24 hrs

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

3 males

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: physiological NaCl
- Time after start of exposure: 24 h

SCORING SYSTEM: DRAIZE; chamber water (clouding) according to MCDONALD and SHADDUCK

TOOL USED TO ASSESS SCORE: fluorescein treatment for observation of epithelial defects under UV light and white light, modified according to MCDONALD and SHADDUCK

Irritation parameter:

cornea opacity score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

chemosis score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Irritant / corrosive response data:

Only one animal (D3) showed a swollen conjunctiva one hour after end of application. However, this effect fully reversed within 24 hours after end of application. All other animals had a DRAIZE-Grade of 0.0 in all observed organs during the entire observation period.

OTHER RESULTS OF IN VIVO STUDY

- Irritation parameter: Fluorescein

- Basis: animal: #1, #2, #3

- Time point: 24 h

- Score: 0.0

- Max. score: 4.0

 

- Irritation parameter: aqueous humour

- Basis: animal: #1, #2, #3

- Time point: 24/48/72 h

- Score: 0.0

- Max. score: 3.0

 

- Irritation parameter: Lacrimation

- Basis: animal: #1, #2, #3

- Time point: 24/48/72 h

- Score: 0.0

- Max. score: 3.0

Interpretation of results:

GHS criteria not met

Conclusions:

In this study, Trimethylcarbonsäure showed no effects on the eyes.

Executive summary:

In a primary eye irritation study performed in accordance with OECD Guideline 405 (Acute Eye Irritation / Corrosion), adopted 24 February 1987, Trimethylcarbonsäure was instilled into the conjunctival sac of adult male albino rabbits (strain New Zealand White) for 24 hours and washed with physiological NaCl.  Animals then were observed for 7 days.  Irritation was scored by the method of DRAIZE and chamber water by the method of MCDONALD and SHADDUCK.

 

Only in one animal chemosis (DRAIZE grade 1) was observed one hour after end of application. However, this effect fully reversed within 24 hours after end of application. Apart from this single observation, no irritation occurred in any animal during the entire observation period.

 

In this study, Trimethylcarbonsäure is not an eye irritant.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Skin irritation

Based on available and relevant data, the test substance does not need to be classified for skin irritation according to regulation (EC) 1272/2008.

Eye irritation

Based on available and relevant data, the test substance does not need to be classified for skin irritation according to regulation (EC) 1272/2008.