Tri-C18-22 (even numbered)-alkyl 2-hydroxypropane-1,2,3-tricarboxylate

Eye irritation

Administrative data

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:

from 1998-09-21 to 1998-09-25

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Tri (hexyl, octyl, decyl) citrate

IUPAC Name:

Tri (hexyl, octyl, decyl) citrate

Constituent 2

Reference substance name:

2-Hydroxypropane-1,2,3-tricarboxylic acid, tri (hexyl, octyl, decyl) ester

IUPAC Name:

2-Hydroxypropane-1,2,3-tricarboxylic acid, tri (hexyl, octyl, decyl) ester

Constituent 3

Reference substance name:

-

EC Number:

430-290-8

EC Name:

-

IUPAC Name:

430-290-8

Details on test material:

- Name of test material (as cited in study report): Tri (hexyl, octyl, decyl) citrate
- Substance type: pure active substance
- Physical state: liquid
- Storage condition of test material: room temperature in a closed container

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Charls River Deutschland GmbH, Kißlegg, Germany
- Age at study initiation: no data
- Weight at study initiation: 3.9 kg, 4.2kg, 3.5 kg
- Housing: individually in ABS - plastic rabbit cages, floor 4200 cm²
- Diet (e.g. ad libitum): Altromin 2123 maintenance diet rabbits ad libitum
- Water (e.g. ad libitum): drinking water ad libitum
- Acclimation period: 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12


IN-LIFE DATES: From: 1998-09-21 To: 1998-09-25

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated eye

Amount / concentration applied:

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

Duration of treatment / exposure:

72 hours

Observation period (in vivo):

1, 24, 48 and 72 hours after application

Number of animals or in vitro replicates:

3 (female)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not done


SCORING SYSTEM: according to guideline


TOOL USED TO ASSESS SCORE: fluorescein solution at the end of the observation period

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Irritant / corrosive response data:

The application of the test item caused minimal blepharospasm in all animals immediately after the application.
1 h after application a slight erythema of the conjunctivae was visible in all animals. 24 h after application two animals showed a slight erythema of the confunctivae. In one animal no alteration were visible as compared to the control eye. The erythema persisted until the 48 h reading in one animal. None of the test animals showed any signs of irritation at the 72 h reading. No corneal leasions were found upon fluorescein examination at the 72 h reading.

Other effects:

No other toxic effects were observed

Any other information on results incl. tables

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	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	1/0/1	0/0/0
48 h	0/0/0	0/0/0	0/0/1	0/0/0
72 h	0/0/0	0/0/0	0/0/0	0/0/0
Average 24h, 48h, 72h	0	0	0.33	0
Reversibility*)	-	-	c.	-
Average time (unit) for reversion	-	-	72 h	-

 

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

 

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test item produced no corrosion or irreversible effects in any of the animals.