Tributyl benzene-1,2,4-tricarboxylate

Endpoint summary

Description of key information

Skin irritation: Not irritant
Eye irritation: Not irritant

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

1989-04-18 to 1989-05-26

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study without detailed documentation. For read across justification see Section 13.

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

no

Species:

rabbit

Strain:

other: Small White Russian

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Fa. Dr. Karl Thomae GmbH, Biberach, Germany
- Age at study initiation: not mentioned
- Weight at study initiation: 2.1 - 2.3 kg
- Housing: single housing in stainless steel cages
- Diet (e.g. ad libitum): K4 complete feed for rabbits, ad libitum, supplied by Ssniff Spezialfutter GmbH, Soest, Germany
- Water (e.g. ad libitum): Drinking water ad libitum
- Acclimation period: 14 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

8 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 10 x 10 cm of shaved skin of the dorsal and lateral parts of the trunk of the animals, application of the test substance on a skin area of approx. 6 cm²
- % coverage: not mentioned
- Type of wrap if used: semi-occlusion with a gauze patch (2.5 cm x 2.5 cm). The patch was secured in position by an elastic bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm water
- Time after start of exposure: 4 hours


SCORING SYSTEM: according to OECD guideline 404

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

1.67

Max. score:

8

Reversibility:

fully reversible within: 6 to 8 days

Irritant / corrosive response data:

AVERAGE SCORE
- Erythema: 1.56
- Edema: 0.11
All animals showed slight to well-defined erythema, and two animals after 1 resp. 24 hours slight edema. Allanimals were free of symptoms after 6 - 8 days.

Other effects:

scurf formation in one animal

Table #: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility	Erythema	Edema
	Max. score: 4	Max. score: 4
60 min	1/2/1	0/1/0
24 h	1/2/2	0/0/1
48 h	1/2/2	0/0/0
72 h	1/2/1	0/0/0
Average 24h, 48h, 72h	1.56	0.11
Reversibility*)	c.	c.
Average time (unit) for reversion	8 days	8 days

 

*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

 

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

All animals showed slight to well-defined erythema, and two animals after 1 resp. 24 hours slight edema. All animals were free of symptoms after 6 - 8 days.
1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters showed a slightly irritant effect on the skin of the test animals with a primary dermal irritation index (PDII) of 1.67/8. The average scores were as follows: Erythema: 1.56, Edema: 0.11

Executive summary:

To test the acute skin irritant effect, 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters was applied to shaven dorsal skin of rabbits. The product was administered undiluted, and the time of exposure in the patch test was 4 hours. The test was carried out in accordance with OECD guideline 404 (12 May 1981).

The test substance showed a slightly irritating effect (primary dermal irritation index (PDII): 1.67) on the skin of male rabbits. Mean Irritation scores derived from the respectice erythema and edema scores for the 24, 48 and 72 hours observations were 1.56 (erythema) and 0.11 (edema).

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:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

1989-05-09 to 1989-05-16

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study without detailed documentation. For read across justification see Section 13.

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

no

Species:

rabbit

Strain:

other: Small White Russian

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach, Germany
- Age at study initiation: not mentioned
- Weight at study initiation: 2.0 - 2.2 kg
- Housing: conventional, singly in stainless steel cages
- Diet (e.g. ad libitum): K4 complete feed for rabbits ad libitum, supplied by Ssniff Spezialfutter GmbH, Soest, Germany
- Water (e.g. ad libitum): Drinking water ad libitum
- Acclimation period: 14 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated eye

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 cm³

Duration of treatment / exposure:

72 hours

Observation period (in vivo):

1, 24, 48 and 72 h and 7 days after treatment

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm physiological saline
- Time after start of exposure: 72 hours


SCORING SYSTEM: according to Draize (Appraisals of the Saftey of Chemicals in Foods, Drugs and Cosmetics, FDA, Austin, Texas 1959, page 51)


TOOL USED TO ASSESS SCORE: ophtmalic lamp, fluorescein 72 hours after administration

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0

Irritant / corrosive response data:

AVERAGE SCORE
- Cornea: 0.0
- Iris: 0.0
- Conjuntivae (Redness): 0.0
- Conjuntivae (Chemosis): 0.0

Other effects:

DESCRIPTION OF LESIONS: 1 hour after application circumcorneal injections in all animals and mild discharge in one animal

Table #: Irritant/corrosive response data for each animal at each observation time of each animal from the test

Score at time point / Reversibility	Cornea	Iris	Conjunctivae	Chemosis
	Max. score: 4	Max. score: 2	Max. score: 3	Max. score: 4
60 min	0/0/0	0/0/0	1/1/1	0/0/0
24 h	0/0/0	0/0/0	0/0/0	0/0/0
48 h	0/0/0	0/0/0	0/0/0	0/0/0
72 h	0/0/0	0/0/0	0/0/0	0/0/0
Average 24h, 48h, 72h	0	0	0	0
Area effected	-	-	-	-
Maximum average score (including area affected, max 110)	0	0	2.67	0
Reversibility*)	-	-	c.	-
Average time (unit) for reversion	-	-	24 hours	-

 

*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

 

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The following mean values, based on the results from the 24 -, 48 - and 72 hour-readings were calculated:
Cornea opacity: 0.0
Iris lesion: 0.0
Redness of conjuntiva: 0.0
Oedema of conjunctiva: 0.0
Based on the result of this study 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters was judged to be non irritating to eyes and mucosa.

Executive summary:

To test the acute irritant effect of 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters on the eyes and mucosa, 0.1 cm³ of the liquid test substance was administered into the conjunctival sac of one eye of each of three male rabbits. After exposure for 72 hours, the eyes were washed out with warm physiological saline. The test was carried out according to OECD guideline 405 (12 May 1982).

The test showed that administration of 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters caused no irritation reactions at cornea and iris. At the conjunctivae 1 hour after application circumcorneal injections in all animals and mild discharge in one animal were observed, after 24 hours all animals were free of symptoms.

The following mean values, based on the results from the 24 -, 48 - and 72 hour-readings were calculated:

Cornea opacity: 0.0

Iris lesion: 0.0

Redness of conjuntiva: 0.0

Oedema of conjunctiva: 0.0

Based on the result of this study 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters was judged to be non irritating to eyes and mucosa.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Acute skin and eye irritation of two structural analogues of the registered substance has been assessed. The irritation observed was not of sufficient severity or persistence for the substances to require classification as either skin or eye irritants.

Justification for selection of skin irritation / corrosion endpoint:
Best documented of the available studies

Justification for selection of eye irritation endpoint:
Best documented of the available studies

Justification for classification or non-classification

Observed response in both skin and eye irritation studies was not of sufficient severity or persistence to require classification according to the criteria stated in Regulation 1272/2008/EC (CLP) and Directive 67/548/EEC (DSD).