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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Description of key information

Amines, di-C16-18 (even-numbered) alkyl (CAS No. 308062-60-4) was tested in two skin irritation/corrosion studies according to the OECD Guideline 404. The key study (Ligget & Smith, 1987) has a reliability rating 2, and is backed up by a supporting study (Guest, 1989) with reliability rating 2.

One test on the corrosive/irritating effects in rabbit eye is available on Amines, bis(hydrogenated tallow alkyl), CAS No 61789-79-5. The test (Arcelin, 2010) is performed according to OECD Guidelines 405 has a reliability rating 1 and was performed under GLP.

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:
30-09-1987 until 24-11-1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
see remarks below
Principles of method if other than guideline:
More animals tested than guideline.
Only 4 hr exposure tested.
GLP compliance:
no
Remarks:
pre-GLP, but inhouse Quality Assurance
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Froxfield rabbits, Peterfield, Hampshire, United Kingdom
- Age at study initiation: 9 to 11 weeks
- Weight at study initiation: 2.0 - 2.8 kg
- Housing: individually in metal cage with perforated floor
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): approximately 19
- Humidity (%): 30 - 70
- Air changes (per hr): 19 changes/hour
- Photoperiod (hrs dark / hrs light): 12 / 12

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 g moistened with 0.5 ml distilled water
Duration of treatment / exposure:
4 hours
Observation period:
0.5 hr after removal of patches and 24, 48 and 72 hours later. Additional observations were made on day 5 through 8.
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 2.5cm x 2.5 cm
- Gauze pad, occluded with Elastoplast elastic adhesive dressing (semi occlusive)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water.
- Time after start of exposure: 4 hours

SCORING SYSTEM:
- see table below.
Irritation parameter:
erythema score
Basis:
mean
Remarks:
all animals 4 hrs exposure
Time point:
24/48/72 h
Score:
1.6
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
mean
Remarks:
all animals 4 hrs exposure
Time point:
24/48/72 h
Score:
1.5
Max. score:
4
Reversibility:
fully reversible within: 6 days
Irritant / corrosive response data:
At the end of the four hour exposure period very slight to moderate irritation was observed in all six animals. These reactions persisted
in five animals up to and including Day 6. The reactions had resolved completely in one animal by Day 2 and in three by Day 7.
Very slight erythema, accompanied in one animal by desquamation of the stratum corneum, persisted in two animals on Day 7, but had resolved
by the following day.

Summary of dermal lesions (following 4-h application)

no.

Effect

Hour

Days after application

Mean score erythema

24/48/72 h

Mean score oedema

24/48/72 h

0.5

1

2

3

4

5

6

2636

Erythema/ eschar

Oedema

2

2

2

2

2

2

2

2

2

3

2

2

1D

0

2

2

2637

Erythema/ eschar

Oedema

2

2

2

3

2

3

2

1

2

2

2

1

0

0

2

2.3

2638

Erythema/ eschar

Oedema

1

1

1

1

1

1

1

0

1

1

1

1

0

0

1

0.7

2639

Erythema/ eschar

Oedema

2

3

2

3

2

3

3

2

3

2

2

2

1

0

2.3

2.7

2640

Erythema/ eschar

Oedema

2

1

2

1

2

1

2

1

1

1

1

1

0

0

2

1

2641

Erythema/ eschar

Oedema

2

1

0

0

0

0

Mean

1.6

1.5

Fa = abnormal fur growth; Fr = reduced fur growth; D = desquamation; T = thickening of skin; R= reactions extending beyond treatment site; Hy = hyperkeratinisation; Br = brown discolourisation of skin; L = loss of skin suppleness; H = haemorrhage of dermal capillaries; Gr = green discoulorisation of skin; Tf = transverse folding of skin; Fi = fissuring of skin; Sc = small scattered scabs; Gs = glossy skin

On day 7 all scores were 0.

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The mean erythema score was 2.3 for one animal. But majority of animals between 1.5 and 2.3.
The mean oedema score was for only two animals 2.3 and 2.7.
No signs of necrosis. Full reversibility.
Executive summary:

A study was performed to assess the effects of Amines, di-C16-18 (even-numbered) alkyl (CAS No. 308062-60-4) on the irritancy potential to the skin of the New Zealand White rabbit. The method used was based on that described in the OECD Guidelines for Testing of Chemicals (1981) No. 404 "Acute Dermal Irritation/Corrosion".

A 4 hours, semi-occluded dermal application of the test material to the intact skin of three rabbits followed by a decontamination procedure with water produced irritation scores directly after patch removal and 1,2 and 3 days afterwards. The erythema/eschar effects were fully reversible within 7 days, the oedema effects were fully reversible in 6 days.

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 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.
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
no
GLP compliance:
yes
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.
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).
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
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
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
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 .

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.

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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Skin

Amines, di-C16-18 (even-numbered) alkyl (CAS No. 308062-60-4) was tested in two skin irritation/corrosion studies according to the OECD Guideline 404.

 

The key study (Ligget & Smith, 1987) has a reliability rating 2, since it was performed pre-GLP in 1987 and no specific certificate of analysis or information on batch is included in the report. In the test a 4 hours, semi-occluded dermal application of 0.5 g of the test substance moistened with 0.5 ml water to the intact skin of three rabbits was performed. A decontamination procedure with water followed and produced irritation scores directly after patch removal and day 1 - 8 afterwards. The erythema/eschar effects were fully reversible within 7 days, the oedema effects were fully reversible in 6 days.The result from this study, showing no corrosion or irritation, is considered to be reliable since the product tested has not changed significantly in its composition since the testing was carried out.

 

The supporting study (Guest, 1989) has a reliability rating 2, since itwas performed pre-GLP in 1989 and no specific certificate of analysis or information on batch is included in the report. In the test 0.5 g of the substance moistened with 0.5 ml distilled water was applied to rabbit skin for two exposure periods of three minutes and one hour respectively. Treatment sites were observed approximately one, 24, 48 and 72 hours after treatment. Although no reaction was observed for any of the two exposure times, classification is not possible since an exposure period of 4 hours is required for classification. Nevertheless, the result from this study is used as supporting evidence to the classification of the substance as not irritating. The result from this study is considered to be representative since the product tested has not changed significantly in its composition since the testing was carried out.

 

 

Eye

The corrosive/irritating effects in rabbit eye following the exposure to Amines, di-C16-18 (even-numbered) alkyl (CAS No. 308062-60-4) was determined according to the OECD Guideline 405 performed under GLP. In the test 0.1 g of undiluted test substance was applied to rabbit eye. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours, as well as 7 days after test item instillation. This study (Arcelin, 2010b) has a reliability rating 1 and shows no permanent damages to rabbit eye, since the slight effects on conjunctivae was fully reversible after 72 hours to 7 days

Justification for classification or non-classification

Skin

The conclusion from the two available studies is that the substance Amines, di-C16-18 (even-numbered) alkyl (CAS No. 308062-60-4) is not to be classified according to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 and is considered “not irritating” to skin.

 

Eye

Based on the above mentioned information, Amines, di-C16-18 (even-numbered) alkyl (CAS No. 308062-60-4) is not classified according to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 and is considered “not irritating” to eye.