Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

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:
study well documented, meets generally accepted scientific principles, acceptable for assessment

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
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
Method: BASF test
50 µl of the test substance were applied to the conjunctival sac of one eye in 2 animals. The animals were observed after 10 min., 1 and 3 h on the day of treatment and up to 8 days afterwards. Findings were recorded daily. The eyes were not washed out after 24 hours as specified in OECD Guideline 405. The report describes findings after 1 and 24 hours and at the end of the observation period.
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Tridecanamine, N-tridecyl-, branched and linear
EC Number:
309-798-8
EC Name:
Tridecanamine, N-tridecyl-, branched and linear
Cas Number:
101012-97-9
Molecular formula:
C24 H50 NH - C28 H58 NH
IUPAC Name:
(2-methyldodecyl)(tridecyl)amine; ditridecylamine
Details on test material:
- Name of test material (as cited in study report): Ditridecylamin techn.
- Physical state: liquid

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: male: 2.35 kg; female: 2.31 kg

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The adjacent eye served as saline control.
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.05 ml
Duration of treatment / exposure:
single application
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
2

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1 h - 24 h - 8 d
Score:
2
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 h
Score:
1
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 h - 8 d
Score:
2
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 8 d
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 8 d
Score:
2
Max. score:
2
Reversibility:
not reversible
Remarks:
Iritis
Irritant / corrosive response data:
Further observations after 24 hours and 8 days: severe redness, distinct edema and severe opacitity, including haemorrhages, staphyloma and suppuration

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria