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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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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:
other: Acceptable, well-documented report which meets basic scientific principles (72 hour reading point is missing).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report date:
1977

Materials and methods

Test guideline
Qualifier:
no guideline followed
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.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Tripropylamine
EC Number:
203-047-7
EC Name:
Tripropylamine
Cas Number:
102-69-2
Molecular formula:
C9H21N
IUPAC Name:
tripropylamine
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Tri-n-propylamin
- Physical state: liquid
- Analytical purity: >= 98 %

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.38 and 2.49 kg

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The adjacent eye served as control and was treated with 0.9 % NaCl (saline).
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µL
Duration of treatment / exposure:
single application
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
2
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

A first test was done with 2 animals. In this test, both animals displayed erythema of similar severity and thus, similar scoring, in the control (0.9% NaCl) eye and the eye treated with the test item. Therefore, the test was repeated with a further 2 animals. In this test, the control eyes were as expected, i.e., without any findings, and thus, this test was considered suitable for assessment of the irritant potential of the test item. The results provided below refer to this test.

SCORING SYSTEM: The findings were re-evaluated according to the Draize scoring system, as recommended by the OECD.

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 hours
Score:
0.75
Max. score:
3
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: 72 h reading is missing
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 hours
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: 72 h reading is missing
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 hours
Score:
0
Max. score:
2
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: 72 h reading is missing
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 hours
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: 72 h reading is missing
Other effects:
After 10 min at one animal eye secretion was noted.

Any other information on results incl. tables

Findings (animal 1):

 Time

Erythema

 Chemosis

 Corneal Opacity

 Iritis

1h

 1

0

0

24h

 1

0

0

48h

 0

 0

0

0

72h

 -

-

-

-

 8d

 0

0

0

 0

Findings (animal 2):

 Time

 Erythema

 Chemosis

Corneal Opacity

Iritis 

1h

1

0

0

0

24h

1

0

0

0

48h

1

0

0

 0

72h

-

-

-

-

 8d

0

 0

 0

 0

Mean values over 24h and 48h (72h reading is missing):

Animal 1: Opacity: 0; Chemosis: 0; Erythema: 0.5

Animal 2: Opacity: 0; Chemosis: 0; Erythema: 1

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Mean conjunctivae score for both animals at 24-h and 48-h reading time points is 0.75. The erythema was fully reversible within 8 days. For cornea and iris, all scores were 0.0 at all reading time points. According to this study result, tripropylamine is likely not irritating to eyes.
Executive summary:

The eye irritation potential of tripropylamine was determined in a test conducted to an internal BASF method. 50 µL of the test substance were applied to the conjunctival sac of one eye in 2 animals (Vienna White rabbits). 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 mean conjunctivae scores for erythema were 0.5 and 1.0 in animal 1 and in animal 2 after 24 -h and 48 -h reading points, respectively (72 -h reading is missing). The mean conjunctivae score for both animals at 24 -h and 48 -h is 0.75. The erythema was fully reversible within 8 days. For cornea and iris, all scores were 0.0 at all reading time points. According to this study result, tripropylamine is likely not irritating to eyes.