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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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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 publication which meets basic scientific principles

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Pentasodium (carboxylatomethyl)iminobis(ethylenenitrilo)tetraacetate
EC Number:
205-391-3
EC Name:
Pentasodium (carboxylatomethyl)iminobis(ethylenenitrilo)tetraacetate
Cas Number:
140-01-2
Molecular formula:
C14H23N3O10.5Na
IUPAC Name:
.
Constituent 2
Reference substance name:
Pentasodium DTPA
IUPAC Name:
Pentasodium DTPA
Details on test material:
Trilon C Flussig
approx 40% pentasodium DTPA
Approx 60% water

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Offenbach, Germany
- Housing: single housing per stainless steel cage (area about 40 x 51 cm)
- Diet (e.g. ad libitum): Ovator Solikanin, Duesseldorf, Germany
- Water (e.g. ad libitum): tap wter (about 250 ml per animal)
- Acclimation period: 8 days before starting the experiment

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 26°C
- Humidity (%): 30 - 70%
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
3
Details on study design:
The acclimatization period was 8 days before starting the study; same housing conditions as during the testing period. Application site: conjunctival sac of the right eye. Observations were made 1 h, 24 h, 48 h, 72 h and 8 days after application. The test substance was not rinsed out.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 h
Score:
6
Max. score:
8
Reversibility:
fully reversible within: 8 days
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 48 h
Score:
4
Max. score:
6
Reversibility:
fully reversible within: 8 days
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 h
Score:
3
Max. score:
5
Reversibility:
fully reversible within: 8 days

Any other information on results incl. tables

 Observations after  Animal No.  Cornea     Iris  Conjunctiva          Single irritation score
     Cloudiness  Area    Reddening  Swelling Secretion     
 24 hours  1  0  0  0  1  0  0    2
   2  0  0  0  2  1  1    8
   3  0  0  0  2  1  1    8
                 Mean  6
 48 hours  1  0  0  0  1  0  0    2
   2  0  0  0  2  0  1    6
   3  0  0  0  1  0  1    4
                 Mean  4
 72 hours  1  0  0  0  1  0  0    2
   2  0  0  0  2  0  1    6
   3  0  0  0  1  0  0    2
                 Mean  3
 8 days  1  0  0  0  0  0  0    0
   2  0  0  0  0  0  0    0
   3  0  0  0  0  0  0    0
                 Mean  0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU