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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Study period:
from April 24, 1996 to May 2, 1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
N,N,N',N'-tetrakis(2-hydroxypropyl)adipamide
EC Number:
260-982-3
EC Name:
N,N,N',N'-tetrakis(2-hydroxypropyl)adipamide
Cas Number:
57843-53-5
Molecular formula:
C18H36N2O6
IUPAC Name:
N,N,N',N'-tetrakis(2-hydroxypropyl)hexanediamide
Test material form:
other: solid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Conditions: Standard Laboratory Conditions.
Air-conditioned with 10 - 15 air changes per hour and continuously monitored environment with target ranges for temperature of 20 ±3 °C and for relative humidity between 40 - 70% (values above 70% during cleaning process possible), 12 hours artificial fluorescent light/12 hours dark, music during the light period.
Accommodation: Individually in stainless steel cages with an automatic equipped with feed hoppers, drinking water bowls and wood for Diet
Diet: Pelleted standard Kliba 341 rabbit maintenance diet (batch 93/96) ad libitum from Kliba Muhlen AG, CH-4303 Kaiseraugst). Results of analysis for contaminants are included in this report.
Water: Community tap water from Itlngen, ad libitum. Results of bacteriological findings/analyses, included in this report.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: right eye for control
Amount / concentration applied:
Solid: 0.1 g / animal (left eye only)
Duration of treatment / exposure:
one second
Observation period (in vivo):
1, 24, 48, 72 h after administration
Number of animals or in vitro replicates:
2 females and 1 male
Details on study design:
The eyes of the animals were examined for intactness once, one day prior to test article administration.
Only those animals with no signs of ocular injury or irritation were used on the test.
At treatment, 0.1 g of the test article (undiluted) was placed in the conjunctival sac of the left eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of the test article. The right eye remained untreated and served as the reference control.
In cases of equivocal results when comparing the treated and untreated eyes, the illustrated guide from the Consumer Product Safety Commission Washington, C. 20207 was used for additional control purposes (Washington, 1977).
The scores of each animal at the following reading times (24, 48 and 72 hours) were used in calculating the respective mean values for each type of lesion
Any findings ascertained during examination were recorded and the numerical irritation scores were assigned thereafter based upon the severity of the individual findings. Therefore, the description of observed findings may differ slightly from the respective numerical irritation scores.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
not specified
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
not specified
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
not specified
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
not specified
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
not specified
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
not specified
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24 h
Score:
0
Max. score:
3
Reversibility:
not specified
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
48 h
Score:
0
Max. score:
3
Reversibility:
not specified
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
3
Reversibility:
not specified
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24 h
Score:
0
Max. score:
3
Reversibility:
not specified
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
48 h
Score:
0
Max. score:
3
Reversibility:
not specified
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
3
Reversibility:
not specified
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24 h
Score:
0
Max. score:
3
Reversibility:
not specified
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
48 h
Score:
0
Max. score:
3
Reversibility:
not specified
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
3
Reversibility:
not specified
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24 h
Score:
0
Max. score:
2
Reversibility:
not specified
Irritation parameter:
iris score
Basis:
animal #1
Time point:
48 h
Score:
0
Max. score:
2
Reversibility:
not specified
Irritation parameter:
iris score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
2
Reversibility:
not specified
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24 h
Score:
0
Max. score:
2
Reversibility:
not specified
Irritation parameter:
iris score
Basis:
animal #2
Time point:
48 h
Score:
0
Max. score:
2
Reversibility:
not specified
Irritation parameter:
iris score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
2
Reversibility:
not specified
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24 h
Score:
0
Max. score:
2
Reversibility:
not specified
Irritation parameter:
iris score
Basis:
animal #3
Time point:
48 h
Score:
0
Max. score:
2
Reversibility:
not specified
Irritation parameter:
iris score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
2
Reversibility:
not specified
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
not specified
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
not specified
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
not specified
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
not specified
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
not specified
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
not specified
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Other effects:
PATHOLOGY
Necropsy
No necropsy was performed on the animals euthanized at termination of observation.
All rabbits were euthanized by an intravenous injection of NARCOREN (Rhone Merieux GmbH, D-88471 Laupheim) into the ear vein at a dose of at least 1.0 ml /kg body weight (equivalent to 160 mg sodium pentobarbitone/kg body weight) and discarded.

Any other information on results incl. tables

 



VIABILITY / MORTALITY AND CLINICAL SIGNS


No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occurred.


IRRITATION                                                                                   


PRIMID QM 1260 showed a primary irritation score of 0.00，when applied to the conjunctival sac of the rabbit eye.


COLORATION


No staining of the cornea, sclera or conjunctivae by the test article was observed.


CORROSION


No corrosion of the cornea was observed at any of the reading  times.


BODY WEIGHTS


The body weight of the animals was within the normal range of variability.


Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
No test-related response was observed in the study and thus, test substance is a non-irritant for eyes of rabbits.
Executive summary:

The primary irritation potential of the test article was investigated by instillation of 0.1 g into one eye of each of three young adult New Zealand rabbits. The treated eyes were not rinsed after application. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours after test article application. The scores of each animal at the following reading times (24, 48 and 72 hours) were used in calculating the respective mean values for each type of lesion. The primary irritation score was calculated by totaling the individual cumulative scores at 24, 48 and 72 hours and then dividing the resulting total by the number of figures. The primary irritation score was 0.00 (max. 13). No staining of the cornea, sclera or conjunctivae of the treated eyes by the test article was observed. No corrosion was observed at any of the measuring intervals. Based on the criteria of CLP (Regulation EC No. 1272/2008), test substance is not to be classified for eye irritation.