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Diss Factsheets

Toxicological information

Eye irritation

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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:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

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
Chemical structure
Reference substance name:
Ascorbic acid
EC Number:
200-066-2
EC Name:
Ascorbic acid
Cas Number:
50-81-7
Molecular formula:
C6H8O6
IUPAC Name:
5-(1,2-dihydroxyethyl)-3,4-dihydroxyfuran-2(5H)-one (non-preferred name)
Specific details on test material used for the study:
CAS number: 50-81-7
Purity: >99%
Batch number: not reported

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd., Wölferstrasse 4, 4414 Fuellinsdorf
- Age at study initiation: 18 (males) to 19 (females) weeks
- Weight at study initiation: 3.1 – 3.2 kg (males), 3.1 – 3.4 kg (females)
- Housing: Individual stainless steel cages equipped with an automatic cleaning and drinking system
- Diet: Pelleted standard Kliba 341 ad libitium, Batch 53/90 rabbit maintenance diet ("Kliba", Klingenthalmuehle AG, 4303 Kaiseraugst, Switzerland)- Water (e.g. ad libitum):
- Acclimation period: 4 days under test conditions after veterenary examination

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

Test system

Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 mL
- Concentration: Saturated solution and 1:3 dilution of saturated solution
Duration of treatment / exposure:
72 hours (not rinsed)
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 male, 3 female
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: Not rinsed

SCORING SYSTEM: According to the OECD TG, adopted February 24, 1987; corneal irritation, iridic irritation and conjunctival irritation

TOOL USED TO ASSESS SCORE: Hand-slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
48 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
48 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
48 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
48 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
48 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
48 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
48 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
48 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
48 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
48 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
48 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
48 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No corrosion of the cornea was observed at any of the measuring intervals.
Other effects:
One hour after instillation of the substance in the eye, conjunctival redness (score 1) was observed in all animals. No further signs of irritation were noted after 1 hour. Conjunctival redness was still observed at the 24-hour obervation point in one animal. No signs of irritation were seen thereafter.

Any other information on results incl. tables

Table 1: Eye Irritation Scores (saturated solution)

Animal Sex Rinsing Cornea opacity Iris Conjunctivae Cumulative score Mean cumulative score
redn. chem.
1 hour
1 M not rinsed 0 0 1 0 1 1.00
2 M not rinsed 0 0 1 0 1
3 M not rinsed 0 0 1 0 1
24 hours
1 M not rinsed 0 0 1 0 1 0.33
2 M not rinsed 0 0 0 0 0
3 M not rinsed 0 0 0 0 0
48 hours
1 M not rinsed 0 0 0 0 0 0.00
2 M not rinsed 0 0 0 0 0 0.00
3 M not rinsed 0 0 0 0 0 0.00
72 hours
1 M not rinsed 0 0 0 0 0 0.00
2 M not rinsed 0 0 0 0 0 0.00
3 M not rinsed 0 0 0 0 0 0.00

M = male

F = female

Table 2: (diluted solution)

Animal Sex Rinsing Cornea opacity Iris Conjunctivae Cumulative score Mean cumulative score
redn. chem.
1 hour
4 F not rinsed 0 0 0 0 0 0.00
5 F not rinsed 0 0 0 0 0
6 F not rinsed 0 0 0 0 0
24 hours
4 F not rinsed 0 0 0 0 0 0.00
5 F not rinsed 0 0 0 0 0
6 F not rinsed 0 0 0 0 0
48 hours
4 F not rinsed 0 0 0 0 0 0.00
5 F not rinsed 0 0 0 0 0
6 F not rinsed 0 0 0 0 0
72 hours
4 F not rinsed 0 0 0 0 0 0.00
5 F not rinsed 0 0 0 0 0
6 F not rinsed 0 0 0 0 0

M = male

F = female

Animal 4 and 6 slightly lost weight during the treatment period. The body weight gain of the remaining rabbits was unaffected.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Slight and reversible signs of irritation were seen within the first 24 hours after treatment with ascorbic acid. The effects were fully reversible within 48 hours. GHS criteria for classification are not met.
Executive summary:

In an OECD 405 study conducted under GLP conditions using 6 rabbits, the test material (ascorbic acid; saturated aqueous solution) was applied into the conjunctival sac of the rabbit eyes. The eyes were examined and reactions were scored at 1, 24, 48, and 72 hours after treatment. The mean overall irritation score was 1.0 at 1 h and 0.33 at 24 h. The effects were fully reversible within 48 hours, i.e. the irritation score was 0.0 (RCC, 1990).

The GHS criteria for classification of ascorbic acid were not met.