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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-compliant guideline study, available as unpublished research, no restrictions, fully adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report date:
2011

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
(2-hydroxyethyl)ammonium dihydrogen citrate
EC Number:
241-814-8
EC Name:
(2-hydroxyethyl)ammonium dihydrogen citrate
Cas Number:
17863-38-6
IUPAC Name:
2-hydroxyethanaminium dihydrogen citrate
Details on test material:
- Name of test material (as cited in study report): (2-hydroxyethyl)ammonium dihydrogen citrate
- Physical state: amber pasty solid
- Analytical purity: 96.4%
- Lot/batch No.: 09301
- Expiration date of the lot/batch: 1 September 2012
- Storage condition of test material: ambient temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Centre Lago
- Age at study initiation: adult
- Weight at study initiation: 5254, 4034 and 4259 g
- Housing: individually in cages (Technilab), fitted with a perforated floor (610 x 610 x 450 mm) with a closed bottom polypropylene box (60 x 40 x 12 cm) with Lignocel 3/4 as bedding placed on the perforated floor. A wooden block was given as cage enrichment.
- Diet: standard laboratory diet (SDS Special Diets services, Whitham, England)
- Water : tap water (N.V. Vitens), ad libitum
- Acclimation period: at least 5 days (animals were reserve animals of other TNO Triskelion studies)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3
- Humidity (%): 45-70
- Air changes (per hr): ca. 10
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the other eye served as an untreated control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
Single instillation
Observation period (in vivo):
1, 24, 48, 72 hours and 7 days
Number of animals or in vitro replicates:
3 females
Details on study design:
SCORING SYSTEM: Draize

The study was carried out because the non-GLP evaluation of eye irritation in vitro using the Isolated Chicken Eye Test (OECD 438) did not reveal signs of severe irritancy. The study was carried out following a sequential rpocedure, i.e. starting with one rabbit and aftert the 1-hour observation (depending on the severity of the eye effects) the next two rabbits.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 + 48 + 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 + 48 + 72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 + 48 + 72 hours
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 + 48 + 72 hours
Score:
0
Max. score:
4
Irritation parameter:
other: ocular discharge
Basis:
mean
Time point:
other: 24 + 48 + 72 hours
Score:
0
Max. score:
3
Irritant / corrosive response data:
At 1 hours after treatment, slight redness and slight swelling of the conjunctivae was observed in the three rabbits. At 24 and 48 hours after treatment, slight redness of the conjunctivae was observed in the three rabbits. At 72 hours after treatment, no signs of irritation were observed in the three rabbits.

Applicant's summary and conclusion