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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
Remarks:
In the OECD SIDS on sodium carbonate (2002) a similar reliability was assigned.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
Minor deviations included housing conditions
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium carbonate
EC Number:
207-838-8
EC Name:
Sodium carbonate
Cas Number:
497-19-8
Molecular formula:
CH2O3.2Na
IUPAC Name:
disodium carbonate
Details on test material:
SOURCE: Chem. Fabrik Kalk GmbH, Köln, Germany
PURITY: Not reported.
IMPURITY/ADDITIVE/ETC.: Not reported.
ANY OTHER INFORMATION: Name (in german) of test substance: "Leichte calc. Soda" (Eng.: Light calcined soda)

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS:
- Sex: Not reported.
- Source: Harald Schriever, Rabbit farm, Germany.
- Age: Not reported.
- Weight at study initiation: 2.4 - 2.6 kg
- Controls: Right eye.

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
undiluted
Amount applied: 0.1 other: g
Duration of treatment / exposure:
72 hour(s)
Number of animals or in vitro replicates:
6
Details on study design:
ADMINISTRATION/EXPOSURE:
- Amount of substance instilled: 0.1 g in left eye; right eye not treated.
- Postexposure period: Up to 72 hr.
EXAMINATIONS
- Ophtalmoscopic examination: Yes.
- Scoring system: Draize scheme
- Observation period: 1, 24, 48, and 72 hr.
- Tool used to assess score: Two independent persons using grade system as described in OECD 405.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
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
Reversibility:
fully reversible
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
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
24
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1 + 24 + 48 + 72 hr
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks:
within 72 hr
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.25
Max. score:
2
Reversibility:
fully reversible within: 72 h
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.25
Max. score:
2
Reversibility:
fully reversible within: 72h
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.25
Max. score:
2
Reversibility:
fully reversible within: 72h
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0.25
Max. score:
2
Reversibility:
fully reversible within: 72 h
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0.25
Max. score:
2
Reversibility:
fully reversible within: 72h
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0.25
Max. score:
2
Reversibility:
fully reversible within: 72h
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1 + 24 + 48 + 72 hr
Score:
0.25
Max. score:
2
Reversibility:
fully reversible
Remarks:
within 72 hr
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.75
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.75
Max. score:
3
Reversibility:
fully reversible within: 72h
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1.75
Max. score:
3
Reversibility:
fully reversible within: 72h
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1.75
Max. score:
3
Reversibility:
fully reversible within: 72h
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 72h
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 + 24 + 48 + 72 hr
Score:
1.67
Max. score:
3
Reversibility:
not fully reversible within: 72 hr in one animal
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.5
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.5
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1.5
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
1.75
Max. score:
4
Reversibility:
not fully reversible within: 72h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1 + 24 + 48 + 72 hr
Score:
1.38
Max. score:
4
Reversibility:
not fully reversible within: 72 hr in one animal
Other effects:
DESCRIPTION OF LESIONS: Not reported.
REVERSIBILITY: All effects were reversible, only one animal showed conjunctival redness and chemosis after 72 hr (score 1), but this score was decreasing.
OTHER EFFECTS: No.

Applicant's summary and conclusion

Interpretation of results:
not irritating

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