Registration Dossier

Administrative data

Description of key information

In an OECD guideline skin irritation test in rabbits, C12-14 ADMAES was corrosive. C12-14 ADMAES is also expected to be corrosive to eyes.

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:
July, 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to OECD Guideline 404 and EU Method B.4 in compliance with GLP.
Reference:
Composition 0
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
GLP compliance:
yes
Test material information:
Composition 1
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Elevage cunicole da Val de Selle, 80160 Prouzel, France
- Weight at study initiation: 2.6 +/- 0.2 kg
- Housing: individually housed
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3°C
- Humidity (%): 30 to 70%
- Photoperiod (hrs dark / hrs light): 12 h dark/ 12 h light

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg
Duration of treatment / exposure:
3 minutes or 4 h
Observation period:
14 days
Number of animals:
3 animals
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test material was removed by gentle swabbing with compress soaked in water
- Time after start of exposure: 3 minutes or 4 h

SCORING SYSTEM: Draize scoring system
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
4
Reversibility:
not fully reversible within: 14 d
Remarks on result:
other: exposure period: 3 minutes
Irritation parameter:
edema score
Basis:
other: range of scores
Time point:
other: 24, 48 and 72 h
Score:
>= 2 - <= 2.7
Max. score:
2.7
Reversibility:
not fully reversible within: 14 d
Remarks on result:
other: exposure period: 3 minutes
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
4
Reversibility:
not fully reversible within: 14 d
Remarks on result:
other: exposure period: 4 hours
Irritation parameter:
edema score
Basis:
other: range of scores
Time point:
other: 24, 48 and 72 h
Score:
>= 2.7 - <= 4
Max. score:
4
Reversibility:
not fully reversible within: 14 d
Remarks on result:
other: exposure period: 4 hours
Irritant / corrosive response data:
Exposure period: 3 minutes
- severe erythema was noted at the treated skin site at 24, 48 and 72 h
- slight edema was noted at the treated skin site at 24, 48 and 72 h

Exposure period: 4 h
- severe erythema was noted at the treated skin site at 24, 48 and 72 h
- slight to severe edema was noted at the treated skin site at 24, 48 and 72 h

Table 1: Individual skin reactions following 3 minutes exposure

Rabbit number Skin reaction 

Scores

Mean irritation score

Scores         

1h / Day 1 24h / Day 2 48 h / Day 3 72h / Day 4   Day 5 Day 6 Day 7 Day 8 Day 9 Day 10 Day 11  Day 12 Day 13 Day 14 Day 15 
# 1  Erythema  3 4.0  LN  LN  LN  LN  LN  LN  DT  DT  LA  LA 
 Edema  0 2.0  LN  LN  LN  LN  LN  LN  DT  DT  LA  LA 
 Other  * N N    N/A A/S  A/S 
# 2  Erythema  2 4.0  LN  LN  LN  LN  LA  LA  LA 
 Edema  0 2.0  LN  LN  LN  LN  LA  LA  LA 
 Other  *   A/S  A/S  A/S 
# 3  Erythema  2 4.0  LN  LN  LN  LN  LA  LA  LA 
 Edema  0  4 2 2.7  LN  LN  LN  LN   LA  LA  LA 
 Other  *  

* no reaction

N = necrosis

S = dry skin

A = crust

DT = tissue destruction

LN = reading masked by necrosis

LA = reading masked by crust

Table 2: Individual skin reactions following 4 hours exposure

Rabbit number Skin reaction 

Scores

Mean irritation score

Scores         

1h /Day 1 24h /Day 2 48 h / Day 3 72h / Day 4   Day 5 Day 6 Day 7 Day 8 Day 9 Day 10 Day 11  Day 12 Day 13 Day 14 Day 15 
# 1  Erythema  4 4.0  LN  LN  LN  LN  LN  LN  LN  LN  DT  DT 
 Edema  4 4.0  LN  LN  LN  LN  LN  LN  LN  LN  DT  DT 
 Other  N N N   N A/S  A/S 
# 2  Erythema  4 4.0  LN  LN  LN  LN  LN  LN  LN  LN  LA  LA  LA 
 Edema  4 2.7  LN LN  LN  LN  LN  LN  LN  LN  LA  LA  LA 
 Other  N N   A/S  A/S  A/S 
# 3  Erythema  4 4.0  LN  LN  LN  LN  LA  LA  LA 
 Edema  4 4 3 3.0 LN  LN  LN  LN   LA  LA  LA 
 Other  N   A/S  A/S  A/S 

* no reaction

N = necrosis

S = dry skin

A = crust

DT = tissue destruction

LN = reading masked by necrosis

LA = reading masked by crust

Interpretation of results:
Category 1C (corrosive)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions, the erythema and edema scores of the test substance was calculated to be 4.0 and ranged from 2.0 to 2.7 (3-minute exposure) and 2.7 to 4.0 (4 h exposure), respectively.
Executive summary:

A OECD guideline study was performed to assess the skin irritation potential of C12-14 ADMAES in New Zealand White rabbits. The test substance (500 mg) was applied to the shaved skin area on the back of each animal under semi-occlusive dressing. A single 3-minute or 4-hour application of the test substance to the intact skin of three rabbits produced severe erythema and oedema. Under the test conditions, the mean erythema and oedema scores were 4.0 (3-minute and 4-hour exposure), and ranged from 2.0 to 2.7 (3-minute exposure) and 2.7 to 4.0 (4-hour exposure), respectively. Effects were not fully reversible within the 14 day observation period. The test substance was considered corrosive to the skin of rabbits.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation
Data waiving:
other justification
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no study available

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin

A OECD guideline study was performed to assess the skin irritation potential of C12-14 ADMAES in New Zealand White rabbits. The test substance (500 mg) was applied to the shaved skin area on the back of each animal under semi-occlusive dressing. A single 3-minute or 4-hour application of the test substance to the intact skin of three rabbits produced severe erythema and oedema. Under the test conditions, the mean erythema and oedema scores were 4.0 (3-minute and 4-hour exposure), and ranged from 2.0 to 2.7 (3-minute exposure) and 2.7 to 4.0 (4-hour exposure), respectively. Effects were not fully reversible within the 14 day observation period. The test substance was considered corrosive to the skin of rabbits (Molinier, 1995).


Justification for selection of skin irritation / corrosion endpoint:
One reliable study conducted according to OECD guidelines.

Justification for selection of eye irritation endpoint:
Data waiving was applied in accordance with Annex VII column 2 of the REACH regulation: the available information regarding skin irritation indicates the substance to be corrosive.

Effects on skin irritation/corrosion: corrosive

Justification for classification or non-classification

Skin

 

In a guideline in vivo skin irritation studyC12-14 ADMAES wascorrosive to skin following a 4-hour semi-occlusive exposure. No effects were observed following a exposure for 3 minutes. Based on these data the following classification is proposed: C; R34 (causes burns) according to Directive 67/548/EEC andskin corrosive category 1C; H314 - causes severe skin burns and eye damage according to Regulation EC 1272/2008.

Eye

Data waiving was applied in accordance with Annex VII column 2 of the REACH regulation as the available information regarding skin irritation indicates the substance to be corrosive.