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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Based on the results of  the read across studies, the test substance is considered to be corrosive to skin and eye.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
July, 1995
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
KL2 due to RA
Justification for type of information:
Refer to the Quaternary ammonium salts (QAS) category or section 13 of IUCLID for details on the category justification.
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system 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
Remarks:
3 minutes
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 4
Max. score:
4
Reversibility:
not fully reversible within: 14 d
Remarks on result:
positive indication of irritation
Irritation parameter:
edema score
Remarks:
3 minutes
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 2.23
Max. score:
4
Reversibility:
not fully reversible within: 14 d
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Remarks:
4 h
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 4
Max. score:
4
Reversibility:
not fully reversible within: 14 d
Remarks on result:
positive indication of irritation
Irritation parameter:
edema score
Remarks:
4 h
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 3.23
Max. score:
4
Reversibility:
not fully reversible within: 14 d
Remarks on result:
positive indication of irritation
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  4  4  4.0  4  LN  LN  LN  LN  LN  LN  DT  DT  LA  LA 
 Edema  0 2  2  2  2.0  2  LN  LN  LN  LN  LN  LN  DT  DT  LA  LA 
 Other  * N N N     N/A N  N  N  N  N  N  A  A  A/S  A/S 
# 2  Erythema  2 4  4  4  4.0  4  4  4  4  LN  LN  LN  LN  LA  LA  LA 
 Edema  0 2  2  2  2.0  2  0  0  0  LN  LN  LN  LN  LA  LA  LA 
 Other  * *  *  *    N  N  N  N  N  N  N  N  A/S  A/S  A/S 
# 3  Erythema  2 4  4  4  4.0  4  4  4  4  LN  LN  LN  LN  LA  LA  LA 
 Edema  0  4 2 2  2.7  2  0  0  0  LN  LN  LN  LN   LA  LA  LA 
 Other  * *  *  N    N  N  N  N  N  N  N  N  A  A  A 

* 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  4  4  4.0  4  LN  LN  LN  LN  LN  LN  LN  LN  DT  DT 
 Edema  4 4  4  4  4.0  4  LN  LN  LN  LN  LN  LN  LN  LN  DT  DT 
 Other  N N N N    N N  N  N  N  N  N  N  N  A/S  A/S 
# 2  Erythema  4 4  4  4  4.0  LN  LN  LN  LN  LN  LN  LN  LN  LA  LA  LA 
 Edema  4 4  2  2  2.7  LN LN  LN  LN  LN  LN  LN  LN  LA  LA  LA 
 Other  N N  N N    N  N  N  N  N  N  N  N  A/S  A/S  A/S 
# 3  Erythema  4 4  4  4  4.0  4  4  4  4  LN  LN  LN  LN  LA  LA  LA 
 Edema  4 4 3 2  3.0 4  0  0  0  LN  LN  LN  LN   LA  LA  LA 
 Other  N N  N  N    N  N  N  N  N  N  N  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)
Conclusions:
Under the study conditions, the test substance was considered to be corrosive to the skin of rabbits.




Executive summary:

A study was conducted to determine the skin irritation potential of read across substance, C12-14 ADMAES (>95% active) in New Zealand White rabbits according to OECD 404 Guideline and EU Method B.4, in compliance with GLP. The read across 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 read across substance to the intact skin of three rabbits produced severe erythema and oedema. Under the study conditions 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. Under the study conditions, the read across substance was considered to be corrosive to the skin of rabbits (Molinier, 1995). Based on the results of the read across, a similar corrosive potential is expected for the test substance.

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

Skin:

A study was conducted to determine the skin irritation potential of read across substance, C12-14 ADMAES (>95% active) in New Zealand White rabbits according to OECD 404 Guideline and EU Method B.4, in compliance with GLP. The read across 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 read across substance to the intact skin of three rabbits produced severe erythema and oedema. Under the study conditions 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. Under the study conditions, the read across substance was considered to be corrosive to the skin of rabbits (Molinier, 1995). Based on the results of the read across, a similar corrosive potential is expected for the test substance.

Eye:

In accordance with Annex VII, Section 8.2, Column 2, an in vitro or in vivo eye irritation study does not need to be conducted because the substance is classified as corrosive to the skin.


Justification for classification or non-classification

Based on the results of the read across in vivo skin irritation studies, the test substance warrants a corrosive, ‘Skin Corr. 1C; H314: Causes severe skin burns and eye damage’ as well as serious eye damage, ‘Eye dam. 1; H31: Causes serious eye damage’ classification according to the EU CLP criteria (Regulation EC 1272/2008). Labelling for this endpoint is covered by the above classifications for skin effects.

With regard to respiratory tract irritation, although C16 TMA MS is a very corrosive substance, its low vapour pressure prohibits the occurrence of respiratory irritation by vapour. Further, the classification of corrosive is already considered to implicitly cover the potential of RTI; therefore an additional Cat.3 is considered to be superfluous (Guidance CLP Ch. 3.8.2.5).