Registration Dossier

Administrative data

Description of key information

Corrosive properties are observed following exposures of 3 minutes and longer, with the skin destruction becoming visible after some delay.

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:
2007-11-16 to 2007-04-04
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-guideline study
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
Principles of method if other than guideline:
not applicable
GLP compliance:
yes (incl. certificate)
Species:
rabbit
Strain:
other: New Zealand White HsdIf:NZW
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, Germany
- Weight at study initiation: 2.13 to 2.7 kg
- Housing: in ABS - plastic rabbit cages, floor 4200cm²
- Diet (e.g. ad libitum): free access to Altromin 2123 maintenance diets for rabbits, rich in crude fibre
- Water (e.g. ad libitum): free access to tap water (microbiologically controlled periodically)
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +- 3°C
- Humidity (%): 55 +- 10%
- Air changes (per hr): at least 10x/h
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
other: Initial test: semiocclusive, additional test: held in place manually
Preparation of test site:
other: clipping
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin areas of the test animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): for the initial test and the additional test 0.5 mL

Duration of treatment / exposure:
initial test: 4h

additional test: 3min
Observation period:
1, 24, 48, 72h after patch removal
Number of animals:
2 (1 animal/ initial test, 1 animal/ additional test)
Details on study design:
TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: small area of approximately 6cm²

REMOVAL OF TEST SUBSTANCE - INITIAL TEST
- Washing : rinsed by using tap water
- Time after start of exposure: at the end of the exposure period (4 h)

REMOVAL OF TEST SUBSTANCE - ADDITIONAL TEST
- Washing : no
- Time after start of exposure: 3 min after start of exposure the patch was removed without washing

SCORING SYSTEM:
according to guideline
Irritation parameter:
other: PSI, initial test
Basis:
animal #1
Time point:
other: average over 24/48/72h
Score:
8
Max. score:
4
Reversibility:
not reversible
Remarks:
animal was euthanized after 72h due to animal welfare reasons
Remarks on result:
other: Necrosis was observed at all times
Irritation parameter:
other: PSI, additional test
Basis:
animal #2
Time point:
other: average over 24/48/72h
Score:
8
Max. score:
4
Reversibility:
not reversible
Remarks:
animal was euthanized after 72h due to animal welfare reasons
Remarks on result:
other: Necrosis was observed after 24h and 48h.
Irritation parameter:
other: result after 3 min, additional test, PSI
Basis:
animal #2
Time point:
other: 3 min
Score:
1
Max. score:
1
Reversibility:
not reversible
Remarks:
within 72h
Remarks on result:
other: Erythema formation was observed immediatly
Irritant / corrosive response data:
Dermal irritation was scored and recorded according to the grades stated in the guidelines. The test item showed severly irritant effects on the intact skin of both rabbits after a contact time of 4h or 3min.
Other effects:
Necrosis was observed, refer to Table 1.
Animal 1 showed weight loss during the observation period.

Table 1: Dermal irritation of animal 1 and 2

3 min

1 h

24 h

48 h

72 h

 Animal number

Erythema

Oedema

 Erythema

 Oedema

 Erythema

 Oedema

 Erythema

 Oedema

 Erythema

 Oedema

 1

initial test

-

-

  3

4*

4

4*

4

  4*

 2 additional test

1

0

 0

2

4*

4

4*

 4

* : necrosis covering half the patch area

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to the criteria of the Commission Directive 2001/59/EC, the test item N-Oleyl-1,3-diaminopropane has to be classified and has obligatory labelling requirement for skin corrosion.
Executive summary:

Acute dermal irritation/corrosion of N-Oleyl-1,3-diaminopropane (liquid) was investigated. 0.5mL of the test substance were applied via a semiocclusive gauze patch to intact clipped skin of one female New Zealand White rabbit and held in place for 4h. At the end of the exposure period, residual test item was rinsed with tap water. In an additional test 0.5mL were applied via a gauze patch to intact clipped skin of another female New Zealand White rabbit and held in place manually for only 3min without subsequent rinsing. Animals were examined for signs of erythema and oedema at 1, 24, 48, 72h after patch removal.

Calculation of Primary Irritation Scores (PIS) as an average value over 24h, 48h and 72h was calculated for each animal. This yielded values of 8 for both animals. Necrosis was observed after 24h in both animals. Irritant effects were not reversible and occurred as early as 3min after exposure (additional test) and persisted. 1 Animal displayed weight loss during the observation period. The symptoms after a contact period of both 4h or 3min required euthanisation of the animals due to animal welfare reasons shortly after the end of the 72h observation period.

Considering the reported data of this irritation study it can be stated that the test item N-Oleyl-1,3-diaminopropane showed severely irritant effects. According to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Directive 2001/59/EC) the test item N-Oleyl-1,3-diaminopropane has to be classified as corrosive and has obligatory labelling requirement for skin irritation.

The test on acute dermal irritation/corrosion was performed under GLP and similar to guideline OECD Guideline 404, EU Method B.4 and EPA OPPTS 870.2500 without deviations.

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

Dermal irritation:

The skin irritation potential of (Z)-N-9-octadecenyl-1,3-diaminopropane (Oleyl diamine) was determined in three guideline studies (OECD 404) performed under GLP. The two most recent studies were performed with different physical states of the substance i.e. liquid and paste, however with only minor differences in the composition. The study performed on the liquid had a slightly higher content of diamines (92.3%) relative to the study performed on the paste (86.2%). However, this difference is not expected to have an impact on the outcome of the studies. Both studies indicated relatively severe necrotic effects that were non-reversible within 72 hours. The oldest study was performed on a substance with a diamine content of 93.6%. This study also demonstrated relatively severe corrosivity. The overall results indicate that (Z)-N-9-octadecenyl-1,3-diaminopropane is corrosive in skin. Following 3 minute application, necrosis was visible the next day, but not yet at one hour after exposure.

 

Eye irritation:

Due to the corrosive response observed in de dermal irritation/corrosion studies with this substance it is not ethical to carry out this animal study. In view of the severe reactions to skin, serious eye damage is to be expected.

 

Respiratory irritation:

There is no study on respiratory irritation available forOleyl diamine.

Oleyl diamine is a liquid/paste witha vapour pressure less than 0.0015 Pa at 20°C (value based on read-across from shorter chain C12-14-diamine). Also the use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalation route will be unlikely to occur. Consequently, despite the irritant nature of the substance, respiratory irritation is not expected.

Justification for classification or non-classification

Available data indicate corrosive properties following exposures of 1 hour and longer. Following exposures, the skin destruction is observed at examination the next day, but not yet at the observation 1 hour after the exposure.Consequently, GHS classification Corrosive Category 1B is appropriate, with hazard statement H314: Causes severe skin burns and eye damage.

 

Due to corrosive properties demonstrated in the dermal irritation/corrosion study with this substance, testing in eyes is not justified. Under GHS with the hazard phrase ‘H314 Causes severe skin burns and eye damage’ additional classification for eyes is not necessary.

 

There is no information is available following exposure via inhalation. However, with a vapour pressure of less than 0.0015 Pa at 20°C, potential for inhalation of vapours is limited.Also the use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalation route will be unlikely to occur.Consequently, despite the irritant nature of the substance, respiratory irritation is not expected, and classification STOT-SE Cat.3 for respiratory irritation is not required.