Registration Dossier

Administrative data

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.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test guidelineopen allclose all
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

Test material

Constituent 1
Reference substance name:
Alcohols, C16-18 (even numbered, C18-unsatd.), ethoxylated, and alcohols C20-22 (even numbered), sulfates, ammonium salts
EC Number:
938-445-6
Molecular formula:
C16H37NO4S - C34H72NO12S
IUPAC Name:
Alcohols, C16-18 (even numbered, C18-unsatd.), ethoxylated, and alcohols C20-22 (even numbered), sulfates, ammonium salts
Test material form:
solid: compact
Details on test material:
- Name of test material (as cited in study report): DE07_2012_001_PLSW
- Physical state: solid
- Lot/Batch No. PU20740016, PU20740019
- Expiration date of lot/batch: 14/03/2014
- Storage condition of test materilal: common room light, room temperature
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

Test animals

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).

Administration / exposure

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

Results and discussion

Effect levels
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.

Applicant's summary and conclusion

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.