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Description of key information

In an acute oral toxicity study with the substance performed in accordance with OECD TG 423, an LD50 of >2000 mg/kg bw was determined.

In an acute dermal toxicity study with the substance performed in accordance with OECD TG 402, an LD50 of >2000 mg/kg bw was determined.

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:
06 March 2001 - 22 March 2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
1996
Qualifier:
according to guideline
Guideline:
other: European Community (EC), Council Directive 67/548/EEC, Annex V, Part B, Methods for the Determination of Toxicity, as last amended by Commission Directive 96/54/EC, Annex IV B, B. 1 tris: "Acute Toxicity (Oral) - Acute Toxic Class Method".
Version / remarks:
1996
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
other: Wistar
Remarks:
Crl:(Wl) BR
Sex:
male/female
Details on test animals or test system and environmental conditions:
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at the initiation of dosing: Young adult animals (approx. 10 weeks old)
- Weight at the initiating of dosing: 379 - 417g(Males) and 211 - 241g (females)
- Fasting period before study: Animals were deprived of food overnight (for a maximum of 20 hours) prior to dosing and until 3-4 hours after administration of the test item.
- Housing: Group housing of 3 animals of the same dosing group in polycarbonate cages (Macrolon MIV type), containing purified sawdust as bedding material.
- Diet: Pelleted rodent diet (Altromin (code VRF 1), Lage, Germany).
- Water: Free access to tap water.
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): approx. 15
- Photoperiod (hrs dark / hrs light): 12/12
Route of administration:
oral: gavage
Vehicle:
propylene glycol
Details on oral exposure:
METHOD: Oral gavage
Frequency: single dosage, on Day 1.

VEHICLE
The vehicle was selected based on trial preparations.

DOSAGE PREPARATION
The formulations (w/w) were prepared within 4 hours prior to dosing. Homogeneity was accomplished to a visually acceptable level. Adjustment was made for specific gravity of vehicle.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
The toxicity of the test substance was assessed by stepwise treatment of groups of 3 animals. The first group was treated at a dose level of 2000 mg/kg body weight. The absence or presence of mortality of animals dosed at one step determined the next step, based on the test procedure defined in the guidelines. The onset, duration and severity of the signs of toxicity were to be taken into account for determination of the time interval between the dose groups.

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality/Moribundity checks: Twice daily
Body weights: Days 1 (pre-administration), 8 and 15.
Clinical signs: At periodic intervals on the day of dosing and once daily thereafter, until day 15.
- Necropsy of survivors performed: All animals assigned to the study were subjected to necropsy and descriptions of all internal macroscopic abnormalities recorded.
- Other examinations performed: none.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
Male: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels: Lethargy, hunched posture, rales, uncoordinated movements and/or chromodacryorrhoea were noted among the animals between days 1 and 3.
Body weight:
The mean body weight gain shown by the animals over the study period was considered to be similar to that expected of normal untreated animals of the same age and strain.
Gross pathology:
No abnormalities were found at macroscopic post mortem examination of the animals.
Interpretation of results:
GHS criteria not met
Conclusions:
In an acute oral toxicity study performed according to OECD 423 and in accordance with GLP principles, an LD50 of >2000 mg/kg bw was determined
Executive summary:

The acute oral toxicity of SPS-1 00 was determined in accordance with OECD guideline 423 and according to GLP principles. The substance was administered by oral gavage to two consecutive groups of 3 Wistar Han rats of each sex at 2000 mg/kg body weight. No mortality occurred. Lethargy, hunched posture, rales, uncoordinated movements and/or chromodacryorrhoea were noted among the animals between days 1 and 3. The body weight gain shown by the animals over the study period was considered to be similar to that expected for normal untreated animals of the same age and strain. No abnormalities were found at macroscopic post mortem examination of the animals. The acute oral toxicity (LD50) was determined to be > 2000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 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:
key study
Study period:
28 February 2001 - 14 March 2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
1987
Qualifier:
according to guideline
Guideline:
other: European Community (EC), Council Directive 67/548/EEC, Annex V, Part B, Methods for the determination of Toxicity, as last amended by Commission Directive 92/69/EEC, B.3: "Acute Toxicity-Dermal"
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes
Species:
rat
Strain:
Wistar
Remarks:
Crl:(WI) BR
Sex:
male/female
Details on test animals or test system and environmental conditions:
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at the initiation of dosing: Young adult animals (approx. 9 weeks old)
- Weight at the initiating of dosing: 348 - 369g (Males) and 206 - 256g (females)
- Housing: Individually housed in polycarbonate cages, containing purified sawdust as bedding material.
- Diet: Pelleted rodent diet (Altromin (code VRF 1), Lage, Germany).
- Water: Free access to tap water.
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): approx. 15
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Vehicle:
propylene glycol
Details on dermal exposure:
TEST SITE
The formulation was applied to a area of approx. 10% of the total body surface, i.e. approx. 25 cm² for males and 18 cm² for females. Animals were clipped the day before application. The test substance was held in contact with the skin with a dressing, consisting of a surgical gauze patch (Surgy 1D), successively covered with aluminium foil and Coban flexible bandage. A piece of Micropore tape* was additionally used for fixation of the bandages in females only.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): water
- Time after start of exposure: 24h

TEST MATERIAL
- Amount(s) applied: 2000 mg/kg (10 ml/kg) body weight.

Duration of exposure:
24h
Doses:
2000 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:
Mortality/Moribundity checks: Twice daily
Body weights: Days 1 (pre-administration), 8 and 15.
Clinical signs: At periodic intervals on the day of dosing and once daily thereafter, until day 15.
- Necropsy of survivors performed: All animals assigned to the study were subjected to necropsy and descriptions of all internal macroscopic abnormalities recorded.
- Other examinations performed: none.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels: Lethargy, chromodacryorrhoea, ptosis, cramped posture, diarrhoea and/or tremors were noted among the animals between days 1 and 5. Hunched posture and/or piloerection
were noted among the animals between days 1 and 12.
Body weight:
The changes noted in body weight gain in males and females were within the range expected for rats used in this type of study and were therefore considered not indicative of toxicity.
Gross pathology:
No abnormalities were found at macroscopic post mortem examination of the animals.
Other findings:
Signs of toxicity (local): General erythema was seen in the treated skin-area of one female between days 2 and 4.
Interpretation of results:
GHS criteria not met
Conclusions:
In an acute oral toxicity study performed according to OECD 402 and in accordance with GLP principles, an LD50 of >2000 mg/kg bw was determined.
Executive summary:

The acute dermal toxicity of SPS-100 was determined in accordance with OECD guideline 402 and according to GLP principles. SPS-100 was administered to five Wistar rats of each sex by dermal application at 2000 mg/kg body weight for 24 hours. No mortality occurred. Lethargy, chromodacryorrhoea, ptosis, cramped posture, diarrhoea and/or tremors were noted among the animals between days 1 and 5. Hunched posture and/or piloerection were noted among the animals between days 1 and 12. General erythema was seen in the treated skin-area of one female between days 2 and 4. The body weight gain shown by the animals over the study period was considered to be similar to that expected for normal untreated animals of the same age and strain. No abnormalities were found at macroscopic post mortem examination of the animals. The acute dermal toxicity (LD50) was determined to be > 2000 mg/kg bw.

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

Additional information

Oral:

The acute oral toxicity of SPS-1 00was determined in accordance with OECD guideline 423 and according to GLP principles. The substance was administered by oral gavage to two consecutive groups of 3 Wistar Han rats of each sex at 2000 mg/kg body weight. No mortality occurred.Lethargy, hunched posture, rales, uncoordinated movements and/or chromodacryorrhoea were noted among the animals between days 1 and3.The body weight gain shown by the animals over the study period was considered to be similar to that expected for normal untreated animals of the same age and strain. No abnormalities were found at macroscopic post mortem examination of the animals. The acute oral toxicity (LD50) was determined to be > 2000 mg/kg bw.

Dermal:

The acute dermal toxicity of SPS-100 was determined in accordance with OECD guideline 402 and according to GLP principles. SPS-100 was administered to five Wistar rats of each sex by dermal application at 2000 mg/kg body weight for 24 hours. No mortality occurred. Lethargy, chromodacryorrhoea, ptosis, cramped posture, diarrhoea and/or tremors were noted among the animals between days 1 and 5. Hunched posture and/or piloerection were noted among the animals between days 1 and 12. General erythema was seen in the treated skin-area of one female between days 2 and 4.The body weight gain shown by the animals over the study period was considered to be similar to that expected for normal untreated animals of the same age and strain. No abnormalities were found at macroscopic post mortem examination of the animals. The acute dermal toxicity (LD50) was determined to be > 2000 mg/kg bw.

Justification for classification or non-classification

Based on the results of the acute oral toxicity study and the acute dermal toxicity study, the substance does not need to be classified for acute oral toxicity or acute dermal toxicity according to Regulation (EC) No. 1272/2008 (CLP Regulation).