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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
Study period:
18 August 1997 - 21 August 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: FHSA 16 CFR 1500.42
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Poly(oxy-1,2-ethanediyl), alpha-[2-[bis(2-aminoethyl)methylammonion)ethyl]-, omega-hydroxy, N,N'-di-Limnanthes alba seed oil acyl derivatives, methyl sulfates (salts)
EC Number:
629-704-1
Cas Number:
226995-92-2
Molecular formula:
The substance is a UVCB - no specific molecular weight or formula is available.
IUPAC Name:
Poly(oxy-1,2-ethanediyl), alpha-[2-[bis(2-aminoethyl)methylammonion)ethyl]-, omega-hydroxy, N,N'-di-Limnanthes alba seed oil acyl derivatives, methyl sulfates (salts)
Test material form:
liquid
Specific details on test material used for the study:
Stored at room temperature and humuidty.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
The pre-test body weight range was 2.1 - 2.3 kg.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
A few seconds
Observation period (in vivo):
1, 2 and 3 days post-administration of substance.
Number of animals or in vitro replicates:
Six

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
animal: 2 animals
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 2 days
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal: 2 eyes
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 2 days
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal: all 6 eyes
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal: all 6 eyes
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal: 4 eyes
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal: all 6 eyes
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
Four of six eyes appeared normal at each observation period. Slight conjunctival irritation, noted in 2/6 eyes, cleared by day 2. There were no abnormal systemic observations.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The substance is not an ocular irritant.
Executive summary:

In an in vivo eye irritation study New Zealand White rabbits (n=6) were exposed to the substance by instillation of the substance into one eye. The corresponding eye of the same animal was left untreated and acted as concurrent control. The eyes were examined at 1, 2 and 3 days post-administration of substance. Four of six eyes appeared normal at each observation period. Slight conjunctival irritation, noted in 2/6 eyes, cleared by day 2. There were no abnormal systemic observations. The substance is not an eye irritant under the conditions of this study.