Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
4.8.1982-18.8.1982
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: A. Tuck and Sons Ltd., Battlesbridge, Essex
- Age at study initiation: ca. 6 weeks
- Weight at study initiation: 104-118g (males), 86-108g (females)
- Fasting period before study: overnight and up to ca. 2 hours after dosing
- Housing: The rats were randomly allocated to cages within treatment groups. They were housed in groups of five in polypropylene cages with sawdust bedding.
- Diet: standard laboratory diet, ad libitum
- Water: ad libitum
- Acclimation period: minimum of 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/- 3
- Humidity (%): Not controlled, but remained within a range of 65-75%RH
- Air changes (per hr): ca. 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 15ml/kg

Doses:
15 ml/kg
No. of animals per sex per dose:
5M, 5F
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed 0.5, 1, 2, 3, 4 and 5 hours following dosing. On subsequent days the animals were observed at least once. Mortalities and evidence of overt toxicity were recorded at each observation. Individual bodyweights were recorded on days 0, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: The macroscopic appearance of abnormal organs was recorded.
Statistics:
An assessment of the acute oral median lethal dose of the test material was made.

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 15 mL/kg bw
Based on:
test mat.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 4 875 mg/kg bw
Based on:
act. ingr.
Mortality:
No mortalities occurred during the fourteen day observation period at a dose level of 15ml/kg test substance, which equates to 3.75 ml/kg active acid.
Clinical signs:
Signs of reaction to treatment observed shortly after dosing in all rats consisted of pilo-erection, abnormal body carriage (hunched posture), lethargy and decreased respiratory rate. Recovery of all rats, as judged by external appearance and behaviour was complete by day 4.
Body weight:
Bodyweight gains of all rats, appeared to be within normal limits throughout the two week observation period.
Gross pathology:
No macroscopic abnormalities were seen in any animal killed at day 14.
Other findings:
None reported.

Any other information on results incl. tables

LD50 >3.75 ml/kg (a.i.)

specific gravity 1.3

LD50 >4875 mg/kg

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The oral LD50 value of >15 ml/kg in rat was reported in a reliable study conducted according to an appropriate protocol and in compliance with GLP. The equivalent LD50 value for the active acid based on this value is >3.75 ml/kg, which is estimated to be equal to 4875 mg/kg active acid. The result is a read across from HMDTMP sodium salt (CAS 56744-47-9
).