Tricalcium dicitrate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from 8-11 Nov 1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study was conducted according to the appropriate OECD test guideline and in compliance with GLP. The study is a read accross from sodium citrate (CAS 68-04-2).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

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:

Trisodium citrate

EC Number:

200-675-3

EC Name:

Trisodium citrate

Cas Number:

68-04-2

Molecular formula:

C6H8O7.3Na

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Charles River, Stolzenseeweg 32-36, D-88353 Kisslegg, GERMANY
- Age at study initiation: 15 wk
- Weight at study initiation: 2.9-3.0 kg
- Housing: 1/ stainless steel cage
- Diet: standared diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 h/12 h

IN-LIFE DATES: From: 1994-11-08 To: 1994-11-11

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated right eye is used as control in each case

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
- Concentration: neat (crystaline powder)

Duration of treatment / exposure:

Exposure from treatment to 72 h.

Observation period (in vivo):

1, 24, 48 and 72 h

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): unwashed

SCORING SYSTEM: according to system given in OECD 405

TOOL USED TO ASSESS SCORE: hand-slit lamp and diagnostic lamp

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Remarks:

Primary Irritation Score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: mean of 24, 48 and 72 h

Score:

0.11

Max. score:

13

Reversibility:

fully reversible within: 48 h

Irritant / corrosive response data:

Eye irritation score 0.11/13 (mean of 3 animals; 24, 48, 72h). Conjunctival redness (grade 2/3) and chemosis (grade 2-3/4) in 2 or 3 animals at 1h, chemosis (grade 1/4) in 1/3 animals at 24h. See also table 1.

Other effects:

No overt systemic toxicity or effect on body weight in observations up to 72 h.

Any other information on results incl. tables

Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

	Cornea	Iris	Conjunctiva
Score at time point / Reversibility			Redness	Chemosis
	Max. score: 4	Max. score: 2	Max. score: 3	Max. score: 4
1 h	0/0/0	0/0/0	0/2/2	1/2/3
24 h	0/0/0	0/0/0	0/0/0	0/0/1
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	0.11/13
Reversibility*	-	-	-	c
Time for reversion	-	-	-	48 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 result is a read accross from sodium citrate (CAS 68-04-2), from a reliable study, conducted according to OECD 405 and GLP, which reported transient irritation and an overall score of 0.11 out of 13. The score was judged in the report to indicate that the test material was not irritating to the eyes of rabbits. This finding would concur with a reading according to EU criteria.