Amines, di-C16-18-alkyl

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from 23-Sep-2009 to 06-Oct-2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

An In vivo study was performed for this substance, since fatty amine based substances frequently produces false negative results for irritation.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N-(C16-C18)alkyl(C16-C18)alkane-1-amine

EC Number:

629-721-4

Cas Number:

308062-60-4

Molecular formula:

No molecular formula

IUPAC Name:

N-(C16-C18)alkyl(C16-C18)alkane-1-amine

Test material form:

solid

Details on test material:

Chemical name: Amines, di-C16-18 (even numbered) alkyl
EC no.: 629-721-4

To the best of knowledge, the sample used is representative to the boundary composition shared and agreed by each registrant.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Animals: Young Adult New Zealand White Rabbit, SPF

Rationale: Recognized by international guidelines as a recommended test system.

Breeder: Harlan France ZI Le Malcourlet 03800 Gannat / France

Number of Animals per Test: 3 (Animals of both sexes were used)

Age (when treated): 16 weeks (male), 16 weeks (females)

Body Weight Range (when treated): 2794 g (male), 2534 - 2888 g (females)

Identification: By unique cage number and corresponding ear number.

Acclimatization: Under laboratory conditions after health examination. Only animals without any visual signs of illness were used for the study.

Randomization: Selected by hand at time of delivery. No computer generated randomization program.

The animals were distributed as follows: Male Number 96, female numbers 97 and 98

Husbandry:
Room Number: 0501 / Harlan Laboratories Ltd., Füllinsdorf
Conditions: Standard Laboratory Conditions. Air-conditioned with 10-15 air changes per hour, and continuously
monitored environment with ranges for room temperature 17-23 °C and for relative humidity between 30-70% (values above 70% during cleaning
process possible), automatically controlled light cycle of 12 hours light and 12 hours dark, music during the daytime light period.

Accommodation: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls. Wood blocks (Harlan Laboratories Ltd,Füllinsdorf) and haysticks 4642 (batch no. 69/08, Provimi Kliba AG) were provided for gnawing.

Diet: Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum (batch nos. 44/09 and 52/09) provided by Provimi Kliba AG, 4303
Kaiseraugst/ Switzerland. Results of analysis for contaminants are archived at Harlan Laboratories Ltd.

Water: Community tap water from Füllinsdorf ad libitum. Results of bacteriological, chemical and contaminant
analyses are archived at Harlan Laboratories Ltd.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.1 g (per animal) of Amines, bis(hydrogenated tallow alkyl) (CAS number: 61789-79-5) was weighed and applied undiluted as it was delivered by the Sponsor.

Duration of treatment / exposure:

Single instillation

Observation period (in vivo):

7 days after instillation

Number of animals or in vitro replicates:

1 male
2 females

Details on study design:

REMOVAL OF TEST ITEM:
- Washing (if done): no washing done
SCORING SYSTEM:
according to the numerical scoring system listed in the Commission Regulation (EC) No 440/2008, B.5. Data were summarized in tabular form, showing for each individual animal the irritation scores for the designated observation time, a description of the degree and nature of irritation, the
presence of serious lesions and non-ocular effects. The scores of each animal at the following reading times (24, 48, 72 hours) were used in calculating the respective mean values (with the exception of the sclerae) for each type of lesion.
TOOL USED TO ASSESS SCORE: Varta Cliptrix diagnostic-lamp (Roth AG, 4153 Reinach /
Switzerland).Varta Cliptrix diagnostic-lamp (Roth AG, 4153 Reinach / Switzerland).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects observed

Remarks on result:

other: individual mean scores: 0 - 0 - 0

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: No effects observed

Remarks on result:

other: individual mean scores: 0 - 0 - 0

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

1.56

Max. score:

3

Reversibility:

fully reversible within: 72 hours to 7 days after instillation

Remarks on result:

other: individual mean scores: 2.00 - 1.00 - 1.67

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

other: no effects in one animal, fully reversible in the two other animals 48 to 72 hours after instillation

Remarks on result:

other: individual mean scores: 0.33 - 0.00 - 0.67

Other effects:

No staining produced by the test item of the treated eye was observed.
White test item remnants were observed in the treated eye or conjunctival sac of all three animals at the 1-hour reading and persisted up to the 24-hour reading in the male and one female.
Slight ocular discharge was present at the 1-hour observation in all animals and lasted up to the 24-hour reading in one female.
Slight to moderate reddening of the sclerae was noted at the 1-hour observation after instillation in all three animals and persisted until the 48-to 72-hour reading .

Any other information on results incl. tables

The instillation of Amines, bis(hydrogenated tallow alkyl) (CAS number: 61789-79-5) into the eye resulted in mild, early-onset and transient ocular changes, such as reddening of the conjunctivae and sclerae, discharge and chemosis.

Slight to moderate reddening of the conjunctivae was noted at the 1-hour observation after instillation in all three animals and persisted as marked to slight until the 72-hour reading (one male) or as moderate to slight until the 48- or 72-hour reading (both females). At the same time, slight to moderate reddening of the sclerae was also observed in all three animals. Slight swelling (chemosis) of the conjunctivae was observed in the male and one female at the 24-hour reading and persisted until the 48-hour reading in the female. Slight ocular discharge was present at the 1-hour observation in all animals and lasted up to the 24-hour reading in one female.

No abnormal findings were observed in the treated eye of any animal 7 days after treatment, the end of the observation period for all animals.

No necropsy was performed at the end of the study.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based upon the referred classification criteria (Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008), Amines, di-C16-18 (even-numbered) alkyl (CAS No. 308062-60-4) is not classified and therefore considered “not irritating” to the rabbit eye.

Executive summary:

The primary eye irritation potential of Amines, di-C16-18 (even-numbered) alkyl (CAS No. 308062-60-4) was investigated according to OECD test guideline no. 405. The test item was applied by instillation of 0.1 g into the left eye of each of three young adult New Zealand White rabbits. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours, as well

as 7 days after test item instillation.

The mean score was calculated across 3 scoring times (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae, separately. The individual mean scores for corneal opacity and iris were 0.00 for all three animals. The individual mean scores for the conjunctivae were 2.00, 1.00 and 1.67 for reddening and 0.33, 0.00 and 0.67 for chemosis, respectively.

The instillation of Amines, di-C16-18 (even-numbered) alkyl (CAS No. 308062-60-4) into the eye resulted in mild, early-onset and transient ocular changes, such as reddening of the conjunctivae and sclerae, discharge and chemosis. These effects were reversible and were no longer evident 7 days after treatment, the end of the observation period for all animals. No abnormal findings were observed in the cornea or iris of any animal at any of the examinations. No corrosion was observed at any of the measuring intervals. White staining of the treated eyes by the test item was observed. No clinical signs were observed.

Thus, the test item did not induce significant or irreversible damage to the rabbit eye.