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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:
supporting study
Study period:
1975
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Only a summary report is available with basic data. Lack of detail on test material

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report date:
1975

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Only the eyes of rabbits not staining with 5% fluorescein in 20 s contact were accepted for the study. Single instillation of 0.005, 0.02, 0.1, or 0.5 mL undiluted or 0.5 ml of 40, 15, 5, or 1% test material dilutions were made into the conjunctival sac of 5 rabbits. The eyes were read immediately unstained and after fluorescein at 24 h, with 1 of 10 grades assigned. Trace or no injury from undiluted test material = Grade 1.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
N-(2-aminoethyl)-N'-[3-(trimethoxysilyl)propyl]ethylenediamine
EC Number:
252-390-9
EC Name:
N-(2-aminoethyl)-N'-[3-(trimethoxysilyl)propyl]ethylenediamine
Cas Number:
35141-30-1
Molecular formula:
C10H27N3O3Si
IUPAC Name:
3,3-dimethoxy-2-oxa-7,10-diaza-3-siladodecan-12-amine

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Diet: Rockland diets ad libitum
- Water: ad libitum (not further specified)

Test system

Vehicle:
other: Both undiluted and diluted in solvent (not further specified) was tested.
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.005, 0.02, 0.1, or 0.5 mL undiluted or 0.5 mLof dilutions
- Concentration (if solution): 40, 15, 5, or 1%
Duration of treatment / exposure:
24 h
Observation period (in vivo):
24 h
Number of animals or in vitro replicates:
5
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM: 1 of 10 grades assigned. Trace or no injury from undiluted test material = Grade 1.

TOOL USED TO ASSESS SCORE: with and without fluorescein

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
out of all animals tetsed
Time point:
other: 24 h
Score:
3
Max. score:
10
Reversibility:
not specified
Remarks on result:
other: Moderate corneal injury with iritis from 0.5 mL undiluted test material per eye; mild or moderate corneal injury from 0.1 mL, with iritis, or 0.02 mL per eye.
Irritant / corrosive response data:
Moderate corneal injury with iritis from 0.5 mL undiluted test material per eye; mild or moderate corneal injury from 0.1 mL, with iritis, or 0.02 mL per eye.
Other effects:
No further effects were reported.

Applicant's summary and conclusion

Conclusions:
The submission substance was tested for its eye irritating properties in a non-guideline study and without GLP compliance. Single instillation of 0.005, 0.02, 0.1, or 0.5 mL undiluted or 0.5 ml of 40, 15, 5, or 1% test material dilutions were made into the conjunctival sac of 5 rabbits. Moderate corneal injury with iritis from 0.5 mL undiluted test material per eye; mild or moderate corneal injury from 0.1 mL, with iritis, or 0.02 mL per eye. Hence, the test item was concluded to be moderately irritating to the eyes.