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Administrative data

Description of key information

No mortalities occurred after oral and dermal exposure, while an inhalation study is waived. All available studies were done according to corresponding guidelines under GLP conditions.

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:
From 5 August 1991 to 28 October 1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: BRL Ltd., Basel, Switzerland
- Age at study initiation: 8 weeks
- Weight at study initiation: males: 197-218 g
females: 155-169 g
- Diet (e.g. ad libitum): free access
- Water (e.g. ad libitum): free access
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 55
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
2000 mg/Kg body weight
No. of animals per sex per dose:
5 males
5 females
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
Sex:
male/female
Dose descriptor:
discriminating dose
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: No mortality
Mortality:
No mortality occurred during the study period
Clinical signs:
No clinical signs of ill health or behavioural changes were seen during the test
Body weight:
The body weight was considered to be similar
Gross pathology:
Macroscopic post mortem examination of the surviving animals at termination did not reveal any abnormalities

INDIVIDUAL ANIMAL OBSERVATIONS - MALES

Dose Level (mg/kg) Observations Number showing effects during day of exposure (hours) Number showing effects during day of observation Total mortality
0,05 2,1 4,15 2 3 4 5 6 7 8 9 10 11 12 13 14 15  
2000 No abnormalities 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5  
Deaths 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0/5

INDIVIDUAL ANIMAL OBSERVATIONS - FEMALE

Dose Level (mg/kg) Observations Number showing effects during day of exposure (hours) Number showing effects during day of observation Total mortality
0,05 2,1 4,15 2 3 4 5 6 7 8 9 10 11 12 13 14 15  
2000 No abnormalities 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5  
Deaths 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0/5
Interpretation of results:
GHS criteria not met
Conclusions:
The oral LD50 value of the substance in rats of either sex was established as exceeding 2000 mg/Kg body weight.
Executive summary:

This study was entitled "Assessment of acute oral toxicity with the substance in the rat". The study was carried out in accordance with the OECD Guideline No. 401, “Acute Oral Toxicity” and EEC Directive 84/449/EEC, Par B.1, “Acute Toxicity-Oral”. No clinical signs of ill health or behavioural changes were observed during the study and no macroscopic abnormalities were seen at necropsy. The oral LD50 value of the substance in rats of either sex was established as exceeding 2000 mg/kg body weight.

The substance cannot be classified and has no obligatory labelling requirement.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw
Quality of whole database:
Study is reliable without restrictions.

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 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:
key study
Study period:
23/10/2007-6/11/2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source:Charles River (UK) Ltd, Margate, Kent, UK
- Housing: individually during the 24-hour exposure period and in group of five, by sex, for the remainder of the study.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure:
- % coverage:
- Type of wrap if used:

REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Constant volume or concentration used: yes/no
- For solids, paste formed: yes/no

VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:
Duration of exposure:
The animals were observed for deaths or overt signs of toxicity 1/2, 1, 2 and 4 hours after dosing and subsequently once daily for fourteen days.
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 females and 5 males per 2000 mg/kg each of them
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
Sex:
male/female
Dose descriptor:
discriminating dose
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality.
Mortality:
There were no deaths
Clinical signs:
There were no signs of systemic toxicity
Body weight:
All animals showed expected gains in bodyweight over the study period
Gross pathology:
No abnormalities were noted at necropsy

Dose Level 2000 mg/kg

    Effect    Notted    after    initiation    of     exposure    (Days)   
  Observation  10  11  12  13  14 
1 - 0 Male / 2 - 0 Female  Erythema 
  Oedema 
  Other  0
1 -1 Male / 2 -1 Female  Erythema 
  Oedema  
  Other 
1 -2 Male / 2 - 2 Female  Erythema   0
  Oedema   0
  Other 
1 - 3 Male / 2 - 3 Female  Erythema 
  Oedema   0
  Other 
1 - 4 Male / 2 - 4 Female  Erythema 
  Oedema 
  Other 
Interpretation of results:
GHS criteria not met
Conclusions:
The acute dermal median lethal dose (LD50) of the test material in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg bodyweight.
Executive summary:

The study was performed to assess the acute dermal toxicity of the test material in the Sprague-Dawley CD strain rat. The method was designed to meet the requirements of the OECD Guidelines for the Testing of Chemicals No. 402 "Acute Dermal Toxciity" and method B3 Acute toxicity (Dermal). A group of ten animals (five males and five females) was given a single, 24 -hour, semi-occluded dermal application of the undiluted 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.

Moratlity: There were no deaths

Clinical observations: There were no signs of systemic toxicity .

Dermal irritation: There were no signs of dermal irritation.

Bodyweight: All animals showed expected gains in bodyweight over the study period.

Necropsy: No abnormalities were noted at necropsy

The acute dermal median lethal dose LD50 of the test material in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg bodyweight.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw
Quality of whole database:
Study is reliable without restrictions.

Additional information

Acute oral toxicity:

The oral LD50 value of the substance in rates of either sex was established as exceeding 2000 mg/kg body weight. Neither mortalities nor clinical signs were observed during the study.

 

Acute inhalation toxicity:

No study data available. Inhalation was not tested as this is not a likely way of entry/route of exposure.

 

Acute dermal toxicity:

The acute dermal toxicity median lethal dose (LD50) of the test material in the Sprague-Dawley strain rat was found to be greater than 2000 mg/kg bodyweight. Neither mortalities norclinical signs were observed during the study.


Justification for selection of acute toxicity – oral endpoint
Sole study available

Justification for selection of acute toxicity – dermal endpoint
Sole study available

Justification for classification or non-classification

- oral toxicity:

Based on the above stated assessment of the acute oral toxicity of the test item, the results from reliable study are above the threshold value given in the CLP Regulation. Therefore the test item does not need to be classified according to Council Directive 2001/59/EC (28th ATP of Directive 67/548/EEC) and according to CLP (Regulation (EC) No 1272/2008 of the European Parliament and of the Council) as implementation of UN-GHS in the EU.

- dermal toxicity:

Based on the above stated assessment of the acute dermal toxicity of the test item, the results from reliable study are above the threshold value given in the CLP Regulation. Therefore the test item does not need to be classified according to Council Directive 2001/59/EC (28th ATP of Directive 67/548/EEC) and according to CLP (Regulation (EC) No 1272/2008 of the European Parliament and of the Council) as implementation of UN-GHS in the EU.

- inhalation toxicity:

No inhalation studies are available and due to exposure considerations the conduct of studies and the classification and labelling for this endpoint is deemed not to be necessary.