Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Comparable to guideline study with acceptable restrictions. Documentation is brief, and observations 48 and 72 h after treatment as required by OECD 405 were not conducted. However, severe lesions persisted until 8 days after treatment. Therefore, the restrictions of the study are acceptable and do not invalidate the study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1970
Report Date:
1970

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
small volume of test substance (0.05 ml)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Tridecylamine, mixture of isomers, technical grade (approx.
95%).

Test animals / tissue source

Species:
rabbit
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: mean 2.9 kg

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: second eye of the same animal treated with NaCl
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.05 ml
- Concentration: undiluted
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
2
Details on study design:
SCORING SYSTEM:
Eye reactions were scored similar to the table contained in OECD TG 405

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 hour
Score:
1
Max. score:
3
Reversibility:
not reversible
Remarks:
within 8 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1 hour
Score:
>= 3 - <= 4
Max. score:
4
Reversibility:
not reversible
Remarks:
within 8 days
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1 hour
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks:
within 8 days
Irritant / corrosive response data:
Corrosion was noted 1 and 24 h after application as substantiated by severe reddening, very severe edema, and severe corneal opacity. Severe chemosis was noted after 8 days. Cornea could not be examined due to suppuration.

Any other information on results incl. tables

Findings:

Findings after 1 hour

Findings after 24 hours

Findings after 8 days

Test substance:

Corrosion

R+/ED+++/OP++

Corrosion

R+/ED+++/OP++

ED++/severe suppuration; eyeball could not be evaluated

NaCl:

Ø

Ø

Ø

R = redness; ED = edema; OP = opacity; Ø = nonirritating; (+) = slight; + = distinct; ++ = severe; +++ = very severe

Applicant's summary and conclusion

Interpretation of results:
highly corrosive
Remarks:
Migrated information
Conclusions:
Classification: risk of serious damage to eyes