11-(heptylamino)undecanoic acid

Endpoint summary

Description of key information

One GLP skin irritation study (Mercier, 1989) was performed according to OECD 404.  N-heptylamino-11- undécanoïc acid was considered as non skin irritant.

One GLP eye irritation sutdy (Mercier, 1989) was performed accoding to OECD 405, N-heptylamino-11- undécanoïc acid was considered as a non eye irritant.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from July 1989 to October 1989

Reliability:

1 (reliable without restriction)

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1981

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Supplier: Charles River
cages: polystyrène ( 560 x 355 x 315 mm).
Temperature of acclimatation: 20 à 26°C
Hygrometry: 33 à 73 % H.R.,

- Diet: approx 150 g per animal et par day (U.A.R. formule 112 - U.A.R., Villemoisson - 91360 Epinay S/Orge - France).
-water : filtered (15 µm), ad libitum (abreuvement automatique). bacteriology check

Animals were acclimatized 7 days before treatment.

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0,5 g, per animal

Duration of treatment / exposure:

One application, 4hours exposure

Observation period:

Readings and observations were done 1, 24, 48 et 72 heures after removing of the semi occlusive paste..

Number of animals:

3 rabbits

Details on study design:

TEST SITE
- Area of exposure:
- % coverage: semi occlusive
- Type of wrap if used:

REMOVAL OF TEST SUBSTANCE

- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
1, 24, 48 and 72 hours

SCORING SYSTEM:
- Method of calculation:Draize method

Irritation parameter:

edema score

Basis:

animal #3

Time point:

72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

animal #2

Time point:

48 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24 h

Score:

0

Max. score:

4

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

72 h

Score:

0

Max. score:

4

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

48 h

Score:

0

Max. score:

4

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

The score for erythema and edema was equal to zero for all animals

Interpretation of results:

GHS criteria not met

Conclusions:

The test item is not a skin irritant.

Executive summary:

The potential irritant and/or corrosive effects of NHAU were evaluated on the skin of New Zealand White rabbits. Each of three rabbits received a 0.5 ml dose of the test article as a single dermal application. The dose was held in contact with the skin under a semi­occlusive binder for an exposure period of four heurs. Following the exposure period, the binder was removed. Test sites were subsequently examined and scored for dermal irritation at 1, 24, 48 and 72 hours following patch removal.
Exposure to the test article produced no erythema or edema in any rabbits. 

Under the condition of the test, the test item,  N-heptylamino-11- undécanoïc acid is considered as non-irritant

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

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)

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

1981

Deviations:

no

GLP compliance:

yes (incl. QA statement)

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

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.

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;

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

Skin irritation Test:

The potential irritant and/or corrosive effects of NHAU were evaluated on the skin of New Zealand White rabbits. Each of three rabbits received a 0.5 ml dose of the test article as a single dermal application. The dose was held in contact with the skin under a semi­occlusive binder for an exposure period of four heurs. Following the exposure period, the binder was removed. Test sites were subsequently examined and scored for dermal irritation at 1, 24, 48 and 72 hours following patch removal.
Exposure to the test article produced no erythema or edema in any rabbits. 

Under the condition of the test, the test item,  N-heptylamino-11- undécanoïc acid is considered as non-irritant.

Eye irritation test:

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.

Justification for classification or non-classification

In the skin irritation test perofmed according to OECD 404, exposure to the test article produced no erythema or edema in any rabbits. N-Heptyl-11-aminoundecanoic acid did not met the CLP or GHS criteria for skin irritation classification.

In the Eye irritation test performed according to OECD 405, 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 Cornea opacity  and 0.37, 0.67 and 1 for iris congestion. N-Heptyl-11-aminoundecanoic acid did not met the CLP or GHS criteria for eye irritation classification.