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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Study period:
no data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1956
Report date:
1956

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
limited documentation, 50 µl instead of 100 µl test substance instilled
Principles of method if other than guideline:
Data on purity are lacking, but as there was no strong irritation observed, this is thought not to impair the evaluation of the eye irritation potential significantly. As a 50% aqueous preparation is the limit of solubility, no higher concentrations would have been achieved if neat AH salt had been tested and this deviation from the test guideline is thought not to impair the evaluation of the eye irritation potential significantly
GLP compliance:
no
Remarks:
pre-GLP study

Test material

Constituent 1
Chemical structure
Reference substance name:
Adipic acid, compound with hexane-1,6-diamine (1:1)
EC Number:
222-037-3
EC Name:
Adipic acid, compound with hexane-1,6-diamine (1:1)
Cas Number:
3323-53-3
Molecular formula:
C6H16N2.C6H10O4
IUPAC Name:
hexanedioic acid - hexane-1,6-diamine (1:1)

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Breeder
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12h/12h

Test system

Vehicle:
water
Controls:
yes, concurrent vehicle
Amount / concentration applied:
TEST MATERIAL
- Concentration (if solution): 50%
Duration of treatment / exposure:
instillation once without rinsing
Observation period (in vivo):
10 minutes, and 1, 3 and 24 hours
Number of animals or in vitro replicates:
2
Details on study design:
REMOVAL OF TEST SUBSTANCE
- The eye was left unwashed.
SCORING SYSTEM:
- Descriptive scores of the raw data have been converted to Draize numerical scores.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
n = 2
Time point:
24 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Remarks:
n = 2
Time point:
24 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
n = 2
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: after 10 min and 1 to 3 hours mean score of 1
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
n = 2
Time point:
24 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Until 3 hours after administration of the test substance, very slight (equivalent to Draize score 0) and transient conjunctivitis was observed in both tested animals. All effects were completely reversible at 24 hours after instillation (no effects were observed in the control eyes treated with physiological saline).
Other effects:
No data

Any other information on results incl. tables

Limited documentation; no further details.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The substance is not irritating to eyes according to EU GHS classification and according to annex VI-Directive 67/548/EEC.
Executive summary:

A saturated (ca. 50%) aqueous solution of the test substance as instilled into one eye of each of two rabbits. For control purpose, physiological saline was instilled into the other eye. Until 3 hours after administration of the test substance, very slight and transient conjunctivitis was observed in both tested animals. All effects were completely reversible at 24 hours after instillation. No effects were observed in the control eyes treated with physiological saline.