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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:
From June 1989 to October 1989
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1981
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
11-(heptylamino)undecanoic acid
EC Number:
271-487-7
EC Name:
11-(heptylamino)undecanoic acid
Cas Number:
68564-88-5
Molecular formula:
C18H37NO2
IUPAC Name:
11-(heptylamino)undecanoic acid
Test material form:
solid
Details on test material:
CAS N°. 68564-88-5
Test item appearance : white solid
.Batch number : 091137

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
- Diet: 150 g par animal/day (U.A.R. formule 112 - U.A.R., Villemoisson - 91360 Epinay-S/Orge - France).
- Water : filtrated water (15 µm),
-acclimatization: animals were acclimatized 12 days before the begenning of treatment

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0,1 ml equivalent to 58 mg of test item.
Duration of treatment / exposure:
24 hours, the animals were then observed for any signs of irritaion
Observation period (in vivo):
24, 48,72 hours
Details on study design:
The study design was established according to available information on the test substance and the above guidelines.
As no irritant effects were anticipated, a single dose of 0.1 ml of the test substance was introduced into the left conjunctival sac of three male New Zealand White rabbits. The right eye served as control.
The test substance was used in its original form.
The eyes were not rinsed after administration of the test substance.
Ocular reactions were observed approximately one hour, 24, 48 and 72 hours after the administration and then daily until reversibility of the ocular reactions.
The mean values of the scores recorded for each animal after 24, 48 and 72 hours were calculated.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Score is 0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: socre is 0
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: score is 0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.67
Max. score:
2
Reversibility:
other: yes after 72hours
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.37
Max. score:
2
Reversibility:
other: Yes after 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: score is 0
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
other: yes
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
other: yes reversible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Score is O
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: score is 0
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: score is 0
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible
Irritant / corrosive response data:
The test item was considered as slightly irritating;

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The substance is not a eye irritant
Executive summary:

The study design was established according to available information on the test substance and the above guidelines.
As no irritant effects were anticipated, a single dose of 0.1 ml of the test substance was introduced into the left conjunctival sac of three male New Zealand White rabbits. The right eye served as control.
The test substance was used in its original form.
The eyes were not rinsed after administration of the test substance.
Ocular reactions were observed approximately one hour, 24, 48 and 72 hours after the administration and then daily until reversibility of the ocular reactions.
The mean values of the scores recorded for each animal after 24, 48 and 72 hours were calculated.


Very slight conjunctival reactions were noted in few animals: very slight  chemosis, very slight conjunctival redness a were observed, all reversible
 comeal opacity score was equal to zera was in all animals.

The mean scores calculated for each animal over 24, 48 and 72 hours were 0.67, 0 and 0 for chemosis, 0.67, 0.67 and 0 for redness of the conjunctiva, 0.0 for Cornela opacity  and 0.37, 0.67 and 1 for iris congestion.
Conclusion
Under our experimental conditions, the test substance NHAU was considered non-irritant when administered by ocular route in rabbits.