Registration Dossier

Administrative data

Description of key information

Acute oral toxicity

Oral LD50combined (rat) = 432 mg/kg bw (95% C.I. 387 - 486 mg/kg bw)

Oral LD50combined (mouse) = ca. 736 mg a.i./kg bw

 

Acute dermal toxicity

A study is not required, as the substance is corrosive.

LD50 extrapolated to be >2000 mg/kg bw based on acute oral data and toxicokinetic data

 

Acute inhalation toxicity

A study is not required, as the substance is corrosive.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Qualifier:
no guideline followed
Principles of method if other than guideline:
only limited information available
GLP compliance:
no
Remarks:
the study was conducted prior to implementation of GLP
Limit test:
no
Species:
mouse
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 30 g (mean)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
Route of administration:
oral: gavage
Doses:
not specified
No. of animals per sex per dose:
not specified
Control animals:
not specified
Details on study design:
not specified
Sex:
male/female
Dose descriptor:
LD50
Effect level:
3.27 mg/kg bw
Based on:
test mat.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 736 mg/kg bw
Based on:
act. ingr.
Mortality:
not specified
Clinical signs:
not specified
Body weight:
not specified
Gross pathology:
not specified
Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
Oral LD50combined = ca. 736 mg a.i./kg bw
Executive summary:

In an acute oral toxicity study, groups of male and female albino mice were given a single oral dose of Reaction product of lauryl-PDA/lauryl-DETA with chloroacetic acid (22.5% aqueous solution) by gavage. Dose levels and observation period were not specified.

 

Oral LD50combined = ca. 736 mg a.i./kg bw

 

According to the criteria laid down in Regulation (EC) No 1272/2008, Reaction product of lauryl-PDA/lauryl-DETA with chloroacetic acid is classified as Acute toxicity, Category 4.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1972
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
the study was conducted prior to implementation of OECD guidelines; procedure however similar to OECD TG 401
GLP compliance:
no
Remarks:
the study was conducted prior to implementation of GLP
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Civo colony
- Weight at study initiation: 103 to 284 g (males) and 147 to 216 g (females)
- Fasting period before study: yes, 16 h
- Housing: groups of 5 in screen-bottomed cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum


Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Remarks:
9% aqueous solution
Doses:
3, 3.5, 4, 4.5, 5, 5.5 mL/kg bw as test material, corresponding to approx. 270, 315, 360, 405, 450 and 495 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Sex:
male/female
Dose descriptor:
LD50
Effect level:
4.8 mL/kg bw
Based on:
test mat.
95% CL:
>= 4.3 - <= 5.4
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
432 mg/kg bw
Based on:
act. ingr.
95% CL:
>= 387 - <= 486
Mortality:
270 mg/kg bw: 0/5 m, 0/5 f
315 mg/kg bw: 0/5 m, 2/5 f
360 mg/kg bw: 2/5 m, 0/5 f
405 mg/kg bw: 2/5 m, 3/5 f
450 mg/kg bw: 1/5 m, 4/5 f
495 mg/kg bw: 2/5 m, 4/5 f
Clinical signs:
Within a few hours after treatment all animals showed slight to severe diarrhoea. The rats became sluggish and looked sick. Deaths occurred during the first five days after dosing. The surviving animals gradually recovered and were quite healthy again after seven days.
Body weight:
no data
Gross pathology:
No abnormalities were seen in the surviving animals at autopsy.
Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
Oral LD50combined = 432 mg/kg bw (95% C.I. 387 - 486 mg/kg bw)
Executive summary:

In an acute oral toxicity study, groups of fasted, young adults Wistar derived rats (5/sex) were given a single oral dose of Reaction product of lauryl-PDA/lauryl-DETA with chloroacetic acid (9% aqueous solution) at doses of  3, 3.5, 4, 4.5, 5, 5.5 mL/kg bw as test material, corresponding to approx. 270, 315, 360, 405, 450 and 495 mg a.i./kg bw and observed for 14 days.

No mortality was observed at 270 mg/kg bw, 2 females died at 315 mg/kg bw, 2 males died at 360 mg/kg bw, 2 males and 3 females died at 405 mg/kg bw, 1 male and 4 females died at, and 2 males and 4 females died at 495 mg/kg bw. Deaths occurred during the first five days after dosing.

Within a few hours after treatment all animals showed slight to severe diarrhoea. The rats became sluggish and looked sick. The surviving animals gradually recovered and were quite healthy again after seven days. No abnormalities were seen in the surviving animals at autopsy.

 

Oral LD50combined = 432 mg/kg bw (95% C.I. 387 - 486 mg/kg bw)

 

According to the criteria laid down in Regulation (EC) No 1272/2008, Reaction product of lauryl-PDA/lauryl-DETA with chloroacetic acid is classified as Acute toxicity, Category 4.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
432 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
according to
Guideline:
other: EPA 40 CFR, Par. 158.50 & 158.135, Subdivision F, Section 81-2, pp. 39 - 44, Nov. 1982
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: at least 2-3 kg
- Diet (e.g. ad libitum): rabbit diet, ad libitum
- Water (e.g. ad libitum): ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature: 65-75°F
- Humidity (%): 40-60%
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: dorso-laterally from.the pectoral to the pelvic areas

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 g/ kg bw

Duration of exposure:
24 h
Doses:
2 g/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: twice daily (clinical signs), once a week (weighing), after 24 and 72 h (irritation)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, skin irritation:
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 450 mg/kg bw
Based on:
act. ingr.
Mortality:
2 females died.
Clinical signs:
depression, diarrhea, laboured breathing
Body weight:
5/8 surviving animals showed weight loss on day 14.
Other findings:
The test item was corrosive.
Interpretation of results:
study cannot be used for classification
Conclusions:
Dermal LD50 Combined > 2000 mg test material/kg bw
Dermal LD50 Combined > 450 mg a.i./kg bw
Executive summary:

In an acute dermal toxicity study according to EPA 40 CFR, Par. 158.50 & 158.135, Subdivision F, Section 81-2, New Zealand White rabbits (5/sex) were dermally exposed to Reaction product of lauryl-PDA/lauryl-DETA with chloroacetic acid (22.5% a.i) for 24 hours at a single dose of 2000 mg/kg bw in terms of test material (corresponding to 450 mg a.i./kg bw). Animals then were observed for 14 days.

2/5 females died during the observation period. 5/8 surviving animals showed weight loss on day 14.

The test item was corrosive to the skin (edema and erythema scores of 4 after 24 and 48 h). The skin sites were severely burned and discoloured black. The skin was thickened and stiff.

 

Dermal LD50 Combined > 2000 mg test material/kg bw

Dermal LD50 Combined > 450 mg a.i./kg bw

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Acute oral toxicity

In an acute oral toxicity study, groups of fasted, young adults Wistar derived rats (5/sex) were given a single oral dose of Reaction product of lauryl-PDA/lauryl-DETA with chloroacetic acid (9% aqueous solution) at doses of 3, 3.5, 4, 4.5, 5, 5.5 mL/kg bw as test material, corresponding to approx. 270, 315, 360, 405, 450 and 495 mg a.i./kg bw and observed for 14 days.

No mortality was observed at 270 mg/kg bw, 2 females died at 315 mg/kg bw, 2 males died at 360 mg/kg bw, 2 males and 3 females died at 405 mg/kg bw, 1 male and 4 females died at, and 2 males and 4 females died at 495 mg/kg bw. Deaths occurred during the first five days after dosing.

Within a few hours after treatment all animals showed slight to severe diarrhoea. The rats became sluggish and looked sick. The surviving animals gradually recovered and were quite healthy again after seven days. No abnormalities were seen in the surviving animals at autopsy.

Oral LD50combined = 432 mg/kg bw (95% C.I. 387 - 486 mg/kg bw)

 

In an acute oral toxicity study, groups of male and female albino mice were given a single oral dose of Reaction product of lauryl-PDA/lauryl-DETA with chloroacetic acid (22.5% aqueous solution) by gavage. Dose levels and observation period were not specified.

Oral LD50combined = ca. 736 mg a.i./kg bw

Comparable results were obtained with the source substance DOPA-Glycinate: The oral LD50 to rat of DOPA-Glycinate was determined to be 660 mg a.i./kg bw for males, 863.6 mg a.i./kg bw for females and 756.6 mg a.i./kg bw for combined sexes. The target substance seems to be slightly more toxic after single administration.

 

Acute dermal toxicity

An acute dermal toxicity study is not required, as the substance is corrosive. However, supporting data are available.

In an acute dermal toxicity study according to EPA 40 CFR, Par. 158.50 & 158.135, Subdivision F, Section 81-2, New Zealand White rabbits (5/sex) were dermally exposed to Reaction product of lauryl-PDA/lauryl-DETA with chloroacetic acid (22.5% a.i) for 24 hours at a single dose of 2000 mg/kg bw in terms of test material (corresponding to 450 mg a.i./kg bw). Animals then were observed for 14 days.

2/5 females died during the observation period. 5/8 surviving animals showed weight loss on day 14.

The test item was corrosive to the skin (edema and erythema scores of 4 after 24 and 48 h). The skin sites were severely burned and discoloured black. The skin was thickened and stiff.

Dermal LD50 Combined > 2000 mg test material/kg bw

Dermal LD50 Combined > 450 mg a.i./kg bw

Based on the available data on oral and dermal absorption, it can be concluded, that the dermal LD50 is >2000 mg/kg bw when extrapolating from the available acute oral toxicity studies.

 

Acute inhalation toxicity

An acute inhalation toxicity study is not required, as the substance is corrosive.

 

According to the criteria laid down in Regulation (EC) No 1272/2008, Reaction product of lauryl-PDA/lauryl-DETA with chloroacetic acid is classified as Acute toxicity, Category 4.

 

There are no data gaps in acute toxicity. Even though there is no information on acute toxicity in humans, there is no reason to believe that the low acute toxicity observed in experimental animals would not be relevant for human health.

Justification for classification or non-classification

According to the criteria laid down in Regulation (EC) No 1272/2008, Reaction product of lauryl-PDA/lauryl-DETA with chloroacetic acid is classified as Acute toxicity, Category 4.