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Administrative data

Description of key information

The substance is of low acute toxicity in mammals by both the oral and dermal routes.

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:
3 July to 25 July 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study carried out according to OECD Guideline 401 (1987); performed according to GLP
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))
GLP compliance:
yes
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): SER-AD FX 511
- Physical state: liquid
- Analytical purity: no data; identity, purity and stability of the test material were the responsibility of the sponsor
- Storage condition of test material: room temperature
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Ltd., Margate, Kent, UK
- Age at study initiation: 5 -8 w
- Weight at study initiation: 145-155 g (males), 135-147 g (females)
- Fasting period before study: overnight before dosing
- Housing: groups of up to five animals of the same sex in solid-floor polypropylene cages furnished with woodflakes
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-24
- Humidity (%): 47-66
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
VEHICLE: no vehicle was used; dose volume applied: 2.15 ml/kg
- Rationale for the selection of the starting dose: a range-finding test was conducted initially so as to determine the appropriate dose for the main study. Two animals ( one male, one female) were treated orally by gavage with a dose of 2000 mg/kg bw
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5/sex/dose group
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: the animals were observed for mortality and clinical signs of toxicity 0.5, 1, 2 and 4 h post-treatment, and once per day for the whole observation period. Body weights were recorded on day 0, 4, and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: gross pathological examination
Statistics:
Not used, not necessary for such a type of study.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
Range-finding study: no death of animals occured. Hunched posture and lethargy were observed, which returned to normal 1 day post-treatment. Hence, the dose of 2000 mg/kg bw was chosen for the main study.
Main study: no animal died during after administration of the test substance
Clinical signs:
Hunched posture, lethargy and ataxia were observed post-treatment. The animals appeared normal 1 day after dosing. Decreased reaspiratory rate was recorded in one male 2-4 hours after administration of the test material, which was reversible and was not obsevred from day 1 post-treatment onwards. No other signs of systemic toxicity were seen.
Body weight:
The body weight gain of treated animals was not affected by the treatment (see below Table1).
Gross pathology:
No treatment-related abnormalities were detected in any of the animals tested in the post-moterm examinations.
Other findings:
- Organ weights: not recorded
- Histopathology: not performed due to no detected abnormalities in the gross pathological examination

Table 1: Individual body weights and weekly body weigh changes in the main study

Dose level (mg/kg bw)

Animal No

Body weight (g) at day

Body weight gaing (g) during week

0

7

14

1

2

2000

Males

1

146

195

233

49

38

2

145

196

244

51

48

3

155

221

280

66

59

4

155

216

270

61

54

5

155

219

281

64

62

Females

1

135

175

206

40

31

2

142

172

200

30

28

3

145

181

209

36

28

4

147

186

207

39

21

5

141

174

198

33

24

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material is of a low order of toxicity following a single oral exposure of rats. The LD50 is >2000mg/kg bw.
Executive summary:

In an acute oral toxicity study, groups of overnight fasted, young adult Sprague-Dawley CD rats 5/sex/dose, were given a single oral dose (by gavage) of 2000 mg/kg bw SER-AD FX 511 (unchanged) and were observed for 14 days. The dose was decided based on a prior-range finding study. The test material was found to be of a low order of acute toxicity following exposure of rats. No mortality was observed. The LD50 for both male and female rats is higher than 2000 mg/kg bw. Clinical signs on the day of dosing included hunched posture, ataxia and lethargy. One animal showed decreased respiratory rate. All clinical symptomps disappeared on day 1 after treatement. All animals except had gained weight 7 and 14 days following dosing. The post-moterm examination revealed no signs of adverse effects. On the basis of this study, SER- AD FX 511 does not warrant classification as being harmful or toxic.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
Sufficient to meet data requirements. The study is Klimisch 1.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
Sufficient to meet data requirements. The study is Klimisch 1.

Additional information

The substance is of low acute toxicity in mammals by both the oral and dermal routes.The acute oral LD50 is > 2000 mg/kg while the acute dermal LD50 is > 2000 mg/kg. Testing by the inhalation route is not scientifically justified.


Justification for selection of acute toxicity – oral endpoint
Only one study available.

Justification for selection of acute toxicity – inhalation endpoint
An acute inhalation toxicity study is scientifically unjustified and is not in the interests of animal welfare. Acute studies are available by the oral and dermal routes.

Justification for selection of acute toxicity – dermal endpoint
Only one study available.

Justification for classification or non-classification

Given the available LD50 values, the substance does not meet the criteria for classification for acute toxicity by either the oral or dermal routes.