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Administrative data

Description of key information

Key studies for oral and dermal acute toxicity were performed, demonstrating LD50 >2000 mg/kg bw after both routes. Inhalation toxicity testing was waived based upon the fact that acute inhalation exposure as such is very unlikely for the test item due to the substance properties and the risk management measures that are already implemented. 

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2012 - 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Guideline study in accordance with EU Method B.1 tris.
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes
Specific details on test material used for the study:
- Name of test material (as cited in study report): DE07_2012_001_PLSW
- Substance type: Alkylsulfate/alkylethersulfate
- Chemical name: Alcohols, C16-18 (even numbered, C18-unsatd.), ethoxylated, and alcohols C20-22 (even numbered), sulfates, ammonium salts
- CAS: n/a
- Physical state: ivory paste-like solid at 20 °C
- Batch No.: PU20740016, PU20740019
- Purity: 100 % (UVCB)
- Storage condition of test material: Room temperature, protected from light
- Stability: stable under test conditions
Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
According to EU Guideline B.1 tris (Acute Toxic Class Method).
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
The test item was emulsified with the vehicle aqua ad injectionem (sterile water) at a concentration of 0.2 g/mL and administered at a dose volume of 10 mL/kg.
Doses:
2000 mg/kg bw (Acute Toxic Class Method)
No. of animals per sex per dose:
Species/strain: healthy rats, WISTAR rats Crl: WI(Han) (full barrier)
Source: Charles River, 97633 Sulzfeld, Germany
Sex: female, non-pregnant, nulliparous
Number of animals: 3 per step
Age at the beginning of the study: 8 - 12 weeks old
Body weight on the day of administration: Step 1 / animals no. 1 - 3: 159 – 168 g; Step 2 / animals no. 4 - 6: 154 – 168 g;

Housing and Feeding Conditions:
- Full barrier in an air-conditioned room
- Temperature: 22 +-3 °C
- Relative humidity: 55 +-10%
- Artificial light, sequence being 12 hours light, 12 hours dark
- Air change: 10 x / hour
- Free access to Altromin 1324 maintenance diet for rats and mice
- Free access to tap water, sulphur acidified to a pH value of approximately 2.8 (drinking water, municipal residue control, microbiological controls at regular intervals)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observations, weighed at days 1, 8 and 15
- Gross necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross necropsy (external examination and opening of abdominal and thoracic cavities to look for macroscopic abnormalities)
Statistics:
Not applicable
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no effects were observed at the highest dose tested, 2000 mg/kg bw
Mortality:
Under the conditions of the present study, a single oral application of the test item DE07_2012_001_PLSW to rats at a dose of 2000 mg/kg body weight was associated with signs of toxicity but not mortality.
Clinical signs:
Moderately reduced spontaneous activity, slight to moderate piloerection, catalepsia and half eyelid-closure was noted in all animals on day one after dosing. 3 of 6 animals appeared normal on day two after dosing. 3 of 6 animals showed slight piloerection on day two after dosing. All animals appeared normal three days after dosing.
Body weight:
None of the animals showed weight loss during the observation period.
Gross pathology:
No specific gross pathological changes were recorded for any animal.
Interpretation of results:
Category 5 based on GHS criteria
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the present study, a single oral application of the test item DE07_2012_001_PLSW to rats at a dose of 2000 mg/kg body weight was associated with signs of toxicity but not mortality. The acute oral median lethal dose (LD50) of the test material in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bodyweight (Globally Harmonised Classification System - Category 5). According to Annex I of Regulation (EC) 1272/2008 the test item DE07_2012_001_PLSW has no obligatory labelling requirement for toxicity and is not classified.
Executive summary:

Introduction:

The study was performed to assess the acute oral toxicity of the test material in the Wistar strain rat. The method was designed to meet the requirements of the following:

- OECD Guideline for Testing of Chemicals No 423

- EU Method B.1 tris Acute toxicity (oral) of Commission Regulation (EC) No. 440/2008 (Acute Toxic Class Method)

 

Method:

Following a test at a dose level of 2000 mg/kg, an additional three female animals were given a single oral dose of test material, as a suspension in water, at a dose level of 2000 mg/kg bodyweight. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.

 

Morality: There were no deaths.

 

Clinical Observations:

Moderately reduced spontaneous activity, slight to moderate piloerection, catalepsia and half eyelid-closure was noted in all animals on day one after dosing. 3 of 6 animals appeared normal on day two after dosing. 3 of 6 animals showed slight piloerection on day two after dosing. All animals appeared normal three days after dosing.

Based on these results and according to the acute toxic class method regime no further testing was required.

Bodyweight:

None of the animals showed weight loss during the observation period.

 

Pathology:

No specific gross pathological changes were recorded for any animal.

 

Conclusion:

Under the conditions of the present study, a single oral application of the test item to rats at a dose of 2000 mg/kg body weight was associated with signs of toxicity but not mortality. The median lethal dose after a single oral administration to female rats, observed over a period of 14 days is: LD50 cut-off (rat): 5000 mg/ kg bw. In conformity with the criteria given in Annex VI to Commission Directive 2001/59/EC the test item has no obligatory labelling requirement for toxicity. According to Annex I of Regulation (EC) 1272/2008 the test item has no obligatory labelling requirement for toxicity and is not classified. According to GHS (Globally Harmonized Classification System) the test item has obligatory labelling requirement for toxicity and is classified into Category 5.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
High quality

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
other justification
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2012 - 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study in accordance with EU method B.3.
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes
Specific details on test material used for the study:
- Name of test material (as cited in study report): DE07_2012_001_PLSW
- Substance type: Alkylsulfate/alkylethersulfate
- Chemical name: Alcohols, C16-18 (even numbered, C18-unsatd.), ethoxylated, and alcohols C20-22 (even numbered), sulfates, ammonium salts
- CAS: n/a
- Physical state: ivory paste-like solid at 20 °C
- Batch No.: PU20740016, PU20740019
- Purity: 100 % (UVCB)
- Storage condition of test material: Room temperature, protected from light
- Stability: stable under test conditions
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
Test animals:
Species/strain: healthy rats, WISTAR rats Crl: WI(Han) (full barrier)
Source: Charles River, 97633 Sulzfeld, Germany
Sex: male and female The female animals were non-pregnant and nulliparous.
Number of animals: 5 male and 5 female
Age: at the beginning of the study: males: 9 weeks old, females: 13 weeks old
Body weight: on the day of administration: males: 231 – 252 g; females: 200 – 220 g.

Housing and Feeding Conditions:

- Temperature: 22 +-3 °C
- Relative humidity: 55 +-10%
- Artificial light, sequence being 12 hours light, 12 hours dark
- Air change: 10 x / hour
- Free access to Altromin 1324 maintenance diet for rats and mice
- Free access to tap water, sulphur acidified to a pH value of approximately 2.8 (drinking water, municipal residue control, microbiological controls at regular intervals)
Type of coverage:
semiocclusive
Vehicle:
water
Details on dermal exposure:
The test item was applied at a single dose, uniformly over an area which was approximately 10% of the total body surface.
The test item was held in contact with the skin by a dressing throughout a 24-hour period. The dressing consisted of a gauze-dressing and non-irritating tape and was fixed with an additional dressing in a suitable manner
Duration of exposure:
The test item was held in contact with the skin throughout a 24-hour period. At the end of the exposure period the residual test item was removed using aqua ad injectionem.
Doses:
The test item was applied at a single dose of 2000 mg/kg bw to each animal.
No. of animals per sex per dose:
5 male and 5 female
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- A careful clinical examination was made several times on the day of dosing (at least once during the first 30 minutes and with special attention given during the first 4 hours post-dose). The animals were weighed on day 1 (prior to the application) and on days 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross necropsy
Statistics:
Not applicable
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
Under the conditions of the present study, single dermal application of the test item to rats at a dose of 2000 mg/kg body weight was associated with with neither mortality nor signs of toxicity.
Clinical signs:
The test item showed no signs of acute dermal toxicity but signs of dermal irritation after a single dose application.
Body weight:
A slight weight loss was recorded for 1 out of 5 female animals during the first week, but all of the female animals showed weight gain during the second week. The effects on weight development might be secondary to the dressing, and toxicological relevance of this finding cannot clearly be concluded. The male animals showed weight gain during the first and the second week of the observation.
Gross pathology:
No specific gross pathological changes were recorded for any animal.
Other findings:
Not applicable
Interpretation of results:
Category 5 based on GHS criteria
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the present study, single dermal application of the test item to rats at a dose of 2000 mg/kg body weight was associated with neither mortality nor signs of toxicity but signs of irritation. The dermal LD50 was determined to be > 2000 mg / kg body weight.
Executive summary:

Introduction:

A study was performed to assess the acute dermal toxicity of the test item in the Wistar strain rat. The method was designed to meet the requirements of the following:

- OECD Guidelines for Testing of Chemicals No 402 “Acute Dermal Toxicity” (adopted 24 February 1987)

- Method B.3 Acute Toxicity (Dermal) of Commission Regulation (EC) No. 440/2008

 

Method:

A group of ten animals (five males and five females) was given a single, 24-hour, semi-occluded dermal application of the test material to intact skin at a dose level of 2000 mg/kg bodyweight. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.

 

Mortality:

There were no deaths.

 

Clinical Observations:

There were no signs of systemic toxicity.

 

Dermal Irritation:

The test item showed signs of irritation. Erythema grade 1 but no oedema was observed in all animals. Desquamation and scratches were also observed in all animals. Eschar was observed in 1 of 5 female animals.

All signs of irritation were reversible within the observation period in all except one female animal.

 

Bodyweight:

A slight weight loss was recorded for 1 out of 5 female animals during the first week, but all of the female animals showed weight gain during the second week. The effects on weight development might be secondary to the dressing, and toxicological relevance of this finding cannot clearly be concluded. The male animals showed weight gain during the first and the second week of the observation.

 

Necropsy:

No abnormalities were noted at necropsy.

Conclusion:

The acute dermal medial lethal dose (LD50) of the test material in the Wistar strain rat was found to be greater than 2000 mg/kg bodyweight.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
High quality

Additional information

Acute oral toxicity:

Acute oral toxicity In a key acute oral toxicity study with the test item the LD50 was >2000 mg act.ingr. /kg bw for female rats. There were no clinical obervations or changes in body weight or macroscopic pathology

Acute dermal toxicity:

In a key acute dermal toxicity study with the test item the LD50 was >2000 mg act.ingr. /kg. for male and female rats. There were no signs of toxicity and no deaths. Signs of skin irritation (very slight erythema - barely perceptible) on the application site were observed in 5 of 5 male and 5 of 5 female animals. All animals gained the expected body weight throughout the whole experimental period and did not elicit gross pathological findings. LD50 was > 2000 mg/kg bw.

Acute inhalation toxicity:

Intoxication due to acute inhalation exposure of industrial workers or even the acute inhalation exposure as such is very unlikely for the test item due to low vapour pressure and application of the substance (aqueous emulsion). Based on these and other physicochemical properties, the inhalation and dermal route are not appropriate, and the default oral route of administration is most appropriate (ECHA R7a Guidance p 342). Additional inhalation testing would therefore neither lead to a better risk assessment, nor improve the safety of applications. On the basis of the argumentation summarized above an acute inhalation toxicity is waived.


Justification for selection of acute toxicity – oral endpoint
Key study

Justification for classification or non-classification