Registration Dossier

Administrative data

Description of key information

Tetradecylamine is considered as causing severe skin burns and eye damage. Tetradecylamine is also considered as causing respiratory irritation.

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Also in compliance with GLP.
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Specific details on test material used for the study:
- Name of test material (as cited in study report): Genamin CC 100 D
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: HOECHST AG, Kastengrund, conventional breed
- Age at study initiation: about 3 -5 months
- Weight at study initiation: 2.4 - 2.8 kg
- Housing: fully air-conditioned rooms, individual cages.
- Diet (e.g. ad libitum): ad libitum (Altromin 2123, Altromin GmbH (Lage/Lippe))
- Water (e.g. ad libitum): ad libitum (deionised, chlorinated water)
- Acclimation period:
- min. 7 days
- daily observation during acclimation period



ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +-3 °C
- Humidity (%): 50 +-20 %
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:
3 min (3 animals)
1 h (3 animals)
Then test substance was removed cautiously from the skin with warm tap-water
Observation period:
30-60 min
24 / 48 / 72 hrs
7 / 14 / 21 days
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: 100 %
0.5mL of the test substance was applied over the whole surface of a 2.5 x 2.5 cm cellulose patch on a piece of surgical plater (specially produced by Beiersdorf AG, Hamburg. The plaster was fixed to the prepared skinarea (ca. 25 cm2) and then covered with a semi-occlusive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with warm tap water
- Time after start of exposure: 3 min (3 animals); 1h(3 animals)


SCORING SYSTEM:

Erythema and eschar formation
No erythema.......................................................................................................................0
very slight erythema (barely perceptible)......................................................................1
well-defined erythema......................................................................................................2
moderate to severe erythema..........................................................................................3
severe erythema (beet redness) to slight eschar formation (lesion in depth).........4

Oedema
No oedema...................................................................................................................................0
very slight oedema (barely perceptible)..................................................................................1
slight oedema (edges of area well defined by definite raising)............................................2
moderate oedema (raised approximately 1mm)....................................................................3
severe oedema (raised more than 1mm and extending beyond area of exposure.........4
Irritation parameter:
erythema score
Remarks:
overall
Basis:
mean
Remarks:
all animals
Time point:
24/48/72 h
Score:
1.9
Max. score:
3
Reversibility:
other: scare formation after 21 days
Remarks on result:
other: exposure 3 minutes
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.7
Max. score:
3
Reversibility:
other: scare formation after 21 days
Remarks on result:
other: exposure 3 minutes
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.7
Max. score:
2
Reversibility:
other: scare formation after 21 days
Remarks on result:
other: exposure 3 minutes
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.33
Max. score:
2
Reversibility:
other: scare formation after 21 days
Remarks on result:
other: exposure 3 minutes
Irritation parameter:
edema score
Remarks:
overall
Basis:
mean
Remarks:
all animals
Time point:
24/48/72 h
Score:
1.7
Max. score:
3
Reversibility:
other: scare formation after 21 days
Remarks on result:
other: exposure 3 minutes
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
other: scare formation after 21 days
Remarks on result:
other: exposure 3 minutes
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.3
Max. score:
2
Reversibility:
other: scare formation after 21 days
Remarks on result:
other: exposure 3 minutes
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
other: scare formation after 21 days
Remarks on result:
other: exposure 3 minutes
Irritation parameter:
erythema score
Remarks:
overall
Basis:
mean
Remarks:
all animals
Time point:
24/48/72 h
Score:
1.77
Max. score:
3
Reversibility:
other: scare formation after 14 - 21 days
Remarks on result:
other: exposure 60 minutes
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.77
Max. score:
2
Reversibility:
other: scare formation after 21 days
Remarks on result:
other: exposure 60 minutes
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
other: scare formation after 21 days
Remarks on result:
other: exposure 60 minutes
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2.67
Max. score:
3
Reversibility:
other: scare formation after 14 days
Remarks on result:
other: exposure 60 minutes
Irritation parameter:
edema score
Remarks:
overall
Basis:
mean
Remarks:
all animals
Time point:
24/48/72 h
Score:
1.33
Max. score:
3
Reversibility:
other: scare formation after 14 - 21 days
Remarks on result:
other: exposure 60 minutes
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
other: scare formation after 21 days
Remarks on result:
other: exposure 60 minutes
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.67
Max. score:
3
Reversibility:
other: scare formation after 21 days
Remarks on result:
other: exposure 60 minutes
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.33
Max. score:
2
Reversibility:
other: scare formation after 14 days
Remarks on result:
other: exposure 60 minutes
Interpretation of results:
Category 1A (corrosive) based on GHS criteria
Conclusions:
Based on the study report and the criteria laid down in the Directive 83/467/EEC or GHS system, the test substance has to be labelled as corrosive (C) with the designation R35 - causes severe burns, or Skin Corr. 1A, H314, respectively.
Executive summary:

In an OECD 404-compliant study, cocoalkylamines were applied on the skin of 6 rabbits. Severe erythema and moderate edema were observed for three minute exposure and one hour exposure time. After 24 hours following removal of the patches the skin was hardened, lumpy and discolored from light-brown to brown/black. The treated area was sharply confined to the untreated skin and in case of the animals with one hour exposure time circumvented with a white rim. From 7 days after removal of the patches, desquamation of coarse scales occurred and in some cases open wounds and 14 to 21 days after removal of the patches eschar formation was observed. The newly build skin was pergament-like, pink and scarred.

Based on the study report and the criteria laid down in the Directive 83/467/EEC or GHS system, the test substance has to be labelled as corrosive (C) with the designation R35 - causes severe burns, or Skin Corr. 1A, H314, respectively.

3 min-exposure:

Time after removal of the patch 30 - 60 min 24 h 48 h 72 h 7 d 14 d 21 d
Animal 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3
erythema and eschar formation 2 4 1 3 1 1 3 2 1 2 2 2 0 1 0 1 0 0 0 0 0
edema 1 1 1 3 2 3 2 1 2 1 1 1 0 0 0 0 0 0 0 0 0

1h-exposure:

Time after removal of the patch 30 - 60 min 24 h 48 h 72 h 7 d 14 d 21 d
Animal 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3
erythema and eschar formation 2 1 2 2 1 3 2 1 3 1 1 2 2 1 1 1 2 0 0 0 0
edema 1 1 1 2 3 2 1 1 1 0 1 1 0 0 0 0 1 0 0 0 0
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In an OECD 404-compliant study, cocoalkylamines were applied on the skin of 6 rabbits. Severe erythema and moderate edema were observed for three minute exposure and one hour exposure time. After 24 hours following removal of the patches the skin was hardened, lumpy and discolored from light-brown to brown/black. The treated area was sharply confined to the untreated skin and in case of the animals with one hour exposure time circumvented with a white rim. From 7 days after removal of the patches, desquamation of coarse scales occurred and in some cases open wounds and 14 to 21 days after removal of the patches eschar formation was observed. The newly build skin was pergament-like, pink and scarred.


Justification for selection of skin irritation / corrosion endpoint:
Only one study available.

Effects on skin irritation/corrosion: highly corrosive

Effects on eye irritation: highly corrosive

Effects on respiratory irritation: irritating

Justification for classification or non-classification

Based on the results of an in vivo study on another member of the chemical category, tetradecylamine is classified as Skin Corr. 1A according to the GHS principles.