Benzene-1,3,5-tricarboxylic acid

Endpoint summary

Description of key information

The test substance is not irritating to skin (Reprotox GmbH, 1981) or eyes (Reprotox GmbH, 1981) of rabbits .

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

October 1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

equivalent or similar to guideline

Guideline:

other: Consumer Product Safety Commision USA (Code of Federal Regulations, Title 16, Section 1500.41)

GLP compliance:

no

Species:

rabbit

Strain:

other: White New Zealand

Details on test animals or test system and environmental conditions:

TEST ANIMALS: 
- Strain: White New Zealand
- Sex: male and female
- Source: J. Scheele, Büderich (Germany)
- Number of animals: 3 males, 3 females

ENVIRONMENTAL CONDITIONS
- Feed: Ssniff K 4 (Ssniff, Soest; Germany)
- Water: tap water ad libitum
- Room temperature: 20°C (+/- 1°C)
- Illumination: 12 hour light/dark rhythm

Type of coverage:

occlusive

Preparation of test site:

other: shaved and scarified

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

ADMINISTRATION/EXPOSURE 
- Vehicle: none
- Total volume applied: 0.5 ml

Duration of treatment / exposure:

24 hour(s)

Observation period:

Postexposure period: 72 hours

Number of animals:

3 per sex

Details on study design:

ADMINISTRATION/EXPOSURE 
- Area of exposure: 6 cm²
- Occlusion: mull patch, polyethylene film, impervious material (such as rubberized cloth)
- Removal of test substance: after 24 hours, no rinsing
- Postexposure period: 72 hours

EXAMINATIONS
- Scoring system: according to Draize
- Examination time points:  24 and  72 hours after administration of the test substance

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24, 72 h

Score:

0

Max. score:

8

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24h, 72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24h, 72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

AVERAGE SCORE
- Erythema: 0
- Edema:  0
- Irritation index: 0

Other effects:

no other effects

Conclusions:

Under the present test conditions, none of the six rabbits exposed for 24 hours to 0.5 mL test item/patch showed any skin reaction.

Executive summary:

The purpose of this study was to examine the test item for acute dermal irritation/corrosion properties in rabbits (patch test).

In a primary skin irritation test with three male and three female rabbits test item applied with occlusive dressing to the shaved and scarified back skin at a dose level of 0.5 mL per animal for 24 h. Residual test substance was not rinsed.

Skin reaction were scored according to ETAD Subcommitee for toxicology at 24h and 72h after application.

Under the present test conditions, none of the six rabbits exposed for 24 hours to 0.5 mL test item/patch showed any skin reaction.

Reference 2

Endpoint:

skin irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Reference 1

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

December 1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

equivalent or similar to guideline

Guideline:

other: Consumer Product Safety Commision USA (Code of Federal Regulations, Title 16, Section 1500.42)

GLP compliance:

no

Species:

rabbit

Strain:

other: White New Zealand

Details on test animals or tissues and environmental conditions:

TEST ANIMALS: 
- Strain: White New Zealand
- Sex: male and female
- Source: J. Scheele, Büderich (Germany)
- Number of animals: 3 males, 3 females

ENVIRONMENTAL CONDITIONS
- Feed: Ssniff K 4 (Ssniff, Soest; Germany)
- Water: tap water ad libitum
- Room temperature: 20°C (+/- 1°C)
- Illumination: 12 hour light/dark rhythm

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

- undiluted
- Amount applied: 0.1 ml
- Controls: untreated eye

Duration of treatment / exposure:

not rinsed

Observation period (in vivo):

 Ophtalmoscopic examination:  24, 48, 72 hours, 7 days after treatment

Number of animals or in vitro replicates:

6

Details on study design:

EXAMINATIONS
- Ophtalmoscopic examination:  24, 48, 72 hours, 7 days after treatment
- Scoring system: Draize (1959)
- Tool used to assess score: Na fluorescein / ophthalmic lamp / visual  inspections

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0.67

Max. score:

110

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24,48, 72 h

Score:

0

Max. score:

80

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

10

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0.55

Max. score:

20

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0.11

Reversibility:

fully reversible within: 48 h

Irritant / corrosive response data:

Irritation Score = 0.67
Conjuntivae score = 0.55
Chemosis score = 0.11

Other effects:

no other effects

Conclusions:

According to the outcome of the study in rabbits slight and reversible conjunctival effects (redness and swelling) were noted in this study.

Executive summary:

In a primary eye irritation study 0.1 mL of undiluted test item was instilled into the conjunctival sac of one eye of three male and three female young adult White New Zealand rabbits. Eyes were not rinsed. Animals were observed for 7 days. 

After the recording of observations at 24 hours, any or all eyes may be further examined after applying fluorescein.

Reactions were scored according to the Draize-Score.

Slight reversible conjunctival effects were observed. 24 hours after administration five animals showed slight redness and one animal showed a slight swelling above normal. Cornea and iris were not affected.

Irritation Score = 0.67

Reference 2

Endpoint:

eye irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available

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

According to the criteria of EC Directive 67/548/EEC and EC Regulation 1272/2008 and based on the results of the in vivo studies the test item is not classified.