Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Name: 7-AMCA
Chemical name: (6R, 7R)-7-Amino-3-methoxymethyl-ceph-3-em-4-carbonic acid
CAS No.: 24701-69-7
Supplier: Sponsor
Batch No.: 8701633
Purity: 96.6 % (content related to water free substance)
Water content: 0.3 %
Appearance: white powder
pH: 3.95 of a 1 % aqueous suspension
Conditions of storage: Refrigerator, in the dark
Stability: Stable under conditions of storage

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Forschungsinstitut für Versuchstierzucht. Himberg. Austria..
- Age at study initiation: Ca. 8 w.
- Weight at study initiation: mean of 213 g for males; mean of 172 g for females.
- Fasting period before study: From the evening before dosing to 3 h after dosing.
- Housing: Single caging
- Diet: Altromin 1314 forte ad libitum
- Water: Tap water ad libitum
- Acclimation period: 6 d.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): ca. 22
- Humidity (%): ca. 55
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
A peroral administration was performed once in the morning by stomach intubation using a metal gavage. The dose volume was 10 mL per kg body weight. The test substance solution was stirred during the time of administration.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 males + 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: 5 times on the first day, then at least once each day.
- Frequency of weighing: before administration, 7 and 14 d p.a.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Male: Number of deaths: 0
Female: Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels: No relevant clinical signs for systemic toxicity were observed.
Body weight:
Body weights: Body weight and body weight gain was inconspicuous in all animals.


Necropsy findings: No abnormal findings were made in the animals at the necropsy 14 d p.a., except for one: In the affected female coverings on glandular stomach mucosa and on spleen surface were found.
Gross pathology:
Necropsy findings: No abnormal findings were made in the animals at the necropsy 14 d p.a., except for one: In the affected female large adrenal glands were observed.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50,oral,rats is higher than 2000 mg/kg body weight.
Executive summary:

The standard acute oral toxicity method according to the EU- and OECD-guidelines was applied. The substance was administered by gavage in a limit dose of 2000 mg/kg body weight to 5 male and 5 female rats.

No mortality occurred. No relevant toxic effects of the test substance were noted by signs in life and post mortem. The oral LD50 was determined to >2000 mg/kg body weight.