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EC number: 201-069-1 | CAS number: 77-92-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 2-16 January 1984
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Remarks:
- Study conducted largely in accordance with the OECD guideline and apparently with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- The report notes that study was conducted according to recommended guidelines of Interagency Regulatory Liaison Group and OECD. The specific guideline is not stated.
- Deviations:
- yes
- Remarks:
- no data on purity, systemic toxicity observations or housing conditions
- GLP compliance:
- yes
- Remarks:
- described as being conducted according to GLP; no details are given
Test material
- Reference substance name:
- Citric acid
- EC Number:
- 201-069-1
- EC Name:
- Citric acid
- Cas Number:
- 77-92-9
- Molecular formula:
- C6H8O7
- IUPAC Name:
- 2-hydroxypropane-1,2,3-tricarboxylic acid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Fűllinsdorf Breeding Farm (no further details given)
- Age at study initiation: "adult"
- Weight at study initiation: not less than 2 kg
- Housing: 1/cage
- Diet: standard ad libitum
- Water: drinking water ad libitum
- Acclimation period: not stated
ENVIRONMENTAL CONDITIONS
-no details given
IN-LIFE DATES: From: 1984-01-2 To: 1984-01-16
Test system
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 ml solution
- Concentration: 10% and 30% aqueous solution
VEHICLE
- Amount(s) applied: sufficient for 0.1 ml solution - Duration of treatment / exposure:
- Unwashed. Exposure/observation for up to 14 days following treatment.
- Observation period (in vivo):
- For 14 days following treatment.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: unwashed
SCORING SYSTEM: Draize (max 110)
TOOL USED TO ASSESS SCORE: not clear
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Remarks:
- mean maximum Draize score for 10% solution
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: at 1, 24, 48 or 72 h
- Score:
- 9.3
- Max. score:
- 110
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: score achieved at 1 h
- Irritation parameter:
- overall irritation score
- Remarks:
- mean maximum Draize score for 30% solution
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: at 1, 24, 48 or 72 h
- Score:
- 16
- Max. score:
- 110
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: score achieved at 1 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Remarks:
- 30% solution
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Remarks:
- 30% solution
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Remarks:
- 30% solution
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Remarks:
- 30% solution
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Remarks:
- 30% solution
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Remarks:
- 30% solution
- Irritant / corrosive response data:
- 30% Aqueous solution of test substance: Conjunctival redness grade 3/3 in 3/3 animals at 1, 24, 48, 72 h; at grade 1/3 in 3/3 at 7 days; at grade 1/3 in 1/3 at 14 days. Chemosis grade 2-3/4 in 3/3 animals at 1, 24, 48, 72 h; at 1/3 in 3/3 at 7 days and in none at 14 days. These effects are reported as well defined to moderate irritation, whereas effects from the 10% solution are reported as moderate to weak.
- Other effects:
- No details are given of clinical observations on systemic toxicity or body weights at study completion.
Any other information on results incl. tables
Table 1: Test with 30% aqueous solution
Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test
Cornea |
Iris |
Conjunctivae |
Discharge |
|||||||
Score at time point / Reversibility |
Opacity |
Area of opacity |
Ulceration visible to the naked eye |
Positive stain retention |
Redness |
Chemosis |
Ulceration (u) |
|||
Max. score: 4 |
Max. score: 4 |
- |
- |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
- |
Max. score: 3 |
||
1 h |
0/0/0 |
- |
0/0/0 |
0/0/0 |
0/0/0 |
3/3/3 |
3/3/3 |
0/0/0 |
2/2/2 |
|
24 h |
0/0/0 |
- |
0/0/0 |
0/0/0 |
0/0/0 |
3/3/3 |
3/3/3 |
u/u/u |
2/2/2 |
|
48 h |
0/0/0 |
- |
0/0/0 |
0/0/0 |
0/0/0 |
3/3/3 |
2/3/2 |
u/u/u |
2/2/2 |
|
72 h |
0/0/0 |
- |
0/0/0 |
0/0/0 |
0/0/0 |
3/3/3 |
2/2/2 |
u/u/u |
2/2/2 |
|
7 days |
0/0/0 |
- |
0/0/0 |
0/0/0 |
0/0/0 |
1/1/1 |
1/1/1 |
0/0/0 |
0/0/0 |
|
14 days |
0/0/0 |
- |
0/0/0 |
0/0/0 |
0/0/0 |
0/1/0 |
0/0/0 |
0/0/0 |
0/0/0 |
|
Average 24h, 48h, 72h |
0/0/0 |
- |
- |
- |
0/0/0 |
3/3/3 |
2.3/2.7/2.3 |
0/0/0 |
2/2/2 |
|
Draize maximum average score @ 1, 24, 48 or 72 h |
0 |
- |
- |
0 |
16 |
|||||
Reversibility** |
- |
- |
- |
- |
- |
n.c. |
c |
- |
c |
|
Time for reversion |
|
by 14 days |
by 14 days |
|
by 7 days |
|||||
* The Draize scoring method is as follows:
Cornea: opacity value x area value x 5. (Max = 80)
Iris: value x 5. (Max = 10)
Conjunctiva: (redness + chemosis + discharge) x 2. (Max = 20)
Total maximum value = 110
** Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
Table 2: Test with 10% aqueous solution
Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test
Cornea |
Iris |
Conjunctivae |
Discharge |
|||||||
Score at time point / Reversibility |
Opacity |
Area of opacity |
Ulceration visible to the naked eye |
Positive stain retention |
Redness |
Chemosis |
Ulceration |
|||
Max. score: 4 |
Max. score: 4 |
- |
- |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
- |
Max. score: 3 |
||
1 h |
0/0/0 |
- |
0/0/0 |
0/0/0 |
0/0/0 |
2/2/2 |
2/1/2 |
0/0/0 |
1/1/1 |
|
24 h |
0/0/0 |
- |
0/0/0 |
0/0/0 |
0/0/0 |
1/1/1 |
0/0/0 |
0/0/0 |
0/0/0 |
|
48 h |
0/0/0 |
- |
0/0/0 |
0/0/0 |
0/0/0 |
1/1/1 |
0/0/0 |
0/0/0 |
0/0/0 |
|
72 h |
0/0/0 |
- |
0/0/0 |
0/0/0 |
0/0/0 |
1/1/1 |
0/0/0 |
0/0/0 |
0/0/0 |
|
7 days |
0/0/0 |
- |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
|
14 days |
0/0/0 |
- |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
|
Average 24h, 48h, 72h |
0/0/0 |
- |
- |
0/0/0 |
1/1/1 |
0/0/0 |
0/0/0 |
0/0/0 |
||
Draize maximum average score @ 1, 24, 48 or 72 h |
0 |
- |
- |
0 |
9.3
|
|||||
Reversibility** |
- |
- |
- |
- |
- |
c |
c |
- |
c |
|
Time for reversion |
|
7 days |
24 h |
|
24 h |
|||||
* The Draize scoring method is as follows:
Cornea: opacity value x area value x 5. (Max = 80)
Iris: value x 5. (Max = 10)
Conjunctiva: (redness + chemosis + discharge) x 2. (Max = 20)
Total maximum value = 110
** Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- A generally reliable study, apparently conducted according to OECD 405 and GLP, reported that a 30% aqueous solution of the test substance caused well defined to moderate conjunctival irritation that had not fully resolved after 14 days. A 10% solution was associated with weak to moderate conjunctival effects, resolved after 7 days. Given the 30% solution effects would have been allowed to dissipate for 21 days, it is likely the test substance would not be considered irritating to the eyes according to EU criteria (please see attached expert letter as reference).
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