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Description of key information

There are two studies available for skin corrosion/irritation on 2, 2’-(Octadec-9-enylimino)bisethanol CAS 25307-17-9.  The first study is a validity one GLP study carried out to OECD404 in 2002, however rather than use of rabbits the study was carried out using weanling domestic pigs.  The second study that is available is a validity 1 study done to GLP following OECD guideline 404.  The study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit.  There are no studies for eye or respiratory irritation. The lack of data on eye irritationis not a concern as the corrosive classification for the skin will also be applied to the eyes via the hazard statement

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:
1990-02-20 - 1990-03-01
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Adequately performed and reported study following OECD 404 guidelines.
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
not specified
Species:
rabbit
Strain:
other: small white Russian, Chbb-SPF
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Fa. Dr. Karl Thomae GmbH, Biberach
- number of animals: 3
- Marking: ear tattoo
- sex: male
- Age at study initiation: no data
- Weight at study initiation: 2,3-2,4 kg
- Housing: indiidual in steelcage
- Diet (e.g. ad libitum): ad libitum. K4 whole rabbit feed from Ssniff Spezialfutter GmbH, 4770 Soest.
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20℃ ± 1℃
- Humidity (%): 60% ± 5%
- Air changes (per hr): 15 /h
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 20.02.1990 To: 01.03.1990
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 cm3
VEHICLE: no
Duration of treatment / exposure:
3 minutes, 1 hour and 4 hours
Observation period:
4 h exposure: 48 hour (and then terminated)
1 h exposure: 72 hour (and then terminated)
3 minutes exposure: up to 8 days.
Number of animals:
3 animals, one for each exposure period.
Details on study design:
TEST SITE
- Area of exposure: approx. 6 cm2
- Type of wrap if used: elastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): careful rinsing with warm water.
- Time after start of exposure: 4 hr, 1 hr and 3 minutes respectively

SCORING SYSTEM:
As liste in OECD guideline
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
4
Reversibility:
not reversible
Irritant / corrosive response data:
Exposure of 0,5 ml resulted to necrosis in following exposure duration of 4 hr, 1 hr and 3 minutes respectively

Results:

Animal exposure observation time
    1 hour 24 hours 48 hours 72 hours 6 days 8 days
    E O E O E O E O E O E O
1 4 hr x4 4 *N4 4 *N4 4          
2 1 hr 2 2 *N4 4 *N4 4 *N4 4      
3 3 min 2 2 *N4 4 *N4 4 *N4 4

*N4

Scp

4

*N4

Scpribl

4

E= erythema; O = Oedema

x = red/brown colouring of the application surface

* = red/brown colouring of the application surface, elevated crust, anemic (white) soft edge around crust.

N = Necrose

Scp = Crust

ri = fissures

bl = bloody

Interpretation of results:
Category 1B (corrosive) based on GHS criteria
Remarks:
Migrated information
Conclusions:
Corrosive following 3 minute application to the skin after 24 hours but not at 1 hour.
Executive summary:

Exposure of the rabbit skin to 0,5 ml of undiluted test substance in acordance to OECD 0404 method, resulted to strong erythem and oedema and after 24 hours necrosis and development of crusts. There was no evidence of corrosion at the 1 hour observation time.

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

There are two studies available for skin corrosion/irritation on 2, 2’-(Octadec-9-enylimino)bisethanol CAS 25307-17-9. 

The firts study that is available is a validity 1 study but done to GLP following OECD guideline 404. The study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. A single 3minute, 1 hour and 4 hour, semi-occluded application of the test material to the intact skin of six rabbits produced severe dermal responses. Necrosis, indicative of dermal corrosion was noted in all dose rabbits at the termination of the animals which for those given the 1 hour exposure was 8 days after exposure. The 2,2’-(Octadec-9-enylimino)bisethanol CAS 25307-17-9 after exposure of 0.5 ml of test substance was corrosive to rabbit skin after 3 minute application. There was no necrosis at 1 hour but it was seen at 24 hours. It was therefore classified as corrosive (Category 1B) to the rabbit skin, according to OECD/GHS criteria.

The second study is a GLP study carried out to OECD 404 in 2002, however rather than use of rabbits the study was carried out using weanling domestic pigs. No mortality or clinical signs of toxicity were observed during the 168-hour observation period. Scab formation was observed on all three animals beginning at the 48 hour observation period and extending to the 168 hour observation period (slight crustation). No exfoliation, hair loss, necrosis or scarring were observed. The maximum PII was 3.3 (moderately irritating).

With results of highly corrosive for skin, similar results are expected for the eyes. Further testing for eye irritation is therefore not indicated.

Justification for classification or non-classification

The rabbit study on 2,2’-(Octadec-9-enylimino)bisethanol CAS 25307-17-9 was used as the basis for classification as it uses the OECD 404 guideline recommended species of the rabbit and therefore the results are comparable with other testing done for classification purposes. The 2,2’-(Octadec-9-enylimino)bisethanol CAS 25307-17-9 after exposure of 0.5ml of test substance was corrosive to rabbit skin after 3 minute application. There was no necrosis at 1 hour but it was seen at 24 hours.  It was therefore classified as corrosive (Category 1B) to the rabbit skin, according to OECD/GHS criteria.

There are no studies on eye irritation with 2,2’-(Octadec-9-enylimino)bisethanol CAS 25307-17-9 but due to the corrosive nature to the skin of the substance it is not ethical to carry out this animal study. The corrosive classification of the 2,2’-(Octadec-9-enylimino)bisethanol and the required risk management methods to avoid eye contact, so the lack of an eye irritation study will not affect the safe handling of the substance. 2,2’-(Octadec-9-enylimino)bisethanol will be considered to be corrosive to eyes based on the effects on the skin. There are no studies to assess the potential for 2,2’-(Octadec-9-enylimino)bisethanol to cause respiratory irritation. The corrosive nature of the 2,2’-(Octadec-9-enylimino)bisethanol would be anticipated to result in respiratory irritation but its physical form as a liquid with a low vapour pressure makes inhalation exposure unlikely, and due to the corrosive nature of the substance use resulting in exposure to aerosols is only expected for dilute solutions.

 

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