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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 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

Constituent 1
Reference substance name:
Trisodium citrate
EC Number:
200-675-3
EC Name:
Trisodium citrate
Cas Number:
68-04-2
IUPAC Name:
trisodium citrate

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.