Registration Dossier

Administrative data

Description of key information

OECD 423 (BASF SE, 2015): 300 < LD50 < 2000 mg/kg bw 

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP- and guideline-conformant study
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. QA statement)
Remarks:
testing lab.
Test type:
acute toxic class method
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, Germany
- Age at study initiation: approx. 10 weeks
- Weight at study initiation:
- Fasting period before study: at least 16 hours before administration
- Housing: single
- Diet: ad libitum (VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany)
- Water: ad libitum (tap water)
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30-70
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12/12
Route of administration:
oral: gavage
Vehicle:
propylene glycol
Doses:
300, 2000 mg/kg bw
No. of animals per sex per dose:
Administration 1: 3 females per dose (300 and 2000 mg/kg bw)
Administration 2: 3 females at 300 mg/kg bw
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observations (several times per on day of administration), weekly weighing
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Sex:
female
Dose descriptor:
LD50
Effect level:
> 300 - < 2 000 mg/kg bw
Based on:
test mat.
Mortality:
2000 mg/kg bw: all aniamls died or were sacrificed in moribound state (3/3)
300 mg/kg bw: no mortalities (0/6)
Clinical signs:
2000 mg/kg bw: impaired general state (3/3), poor general state (3/3), dyspnoea (3/3), piloerection (3/3), lacrimation (1/3), abdominal position (1/3), staggering (3/3), cowering position (2/3), exsiccosis (2/3), diarrhea (1/3), reduced defecation (2/3), black discolored feces (2/3), body weight loss (2/3)
300 mg/kg bw: impaired general state (6/6), piloerection (6/6), dyspnoea (3/6), staggering (2/6)
Body weight:
Body weight increase was normal in surviving animals
Gross pathology:
300 mg/kg bw: no macroscopic findings
Other findings:
Macroscopic pathological findings in the animal that died and in the animals that were sacrificed moribund: dark red, spotted discoloration of all lung lobes; stomach inflated with gas; blue discoloration of the stomach contents; red discoloration of the small intestines contents
o Red discoloration of the small intestine; appendix and small intestine fully filled with black discolored liquid

Dose (mg/kg bw)

2000

300

300

Administration

1

1

2

No. of animals

3

3

3

mortalities

1

0

0

sacrificed in moribound state

2

0

0

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
300 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In an acute oral toxicity study performed according to the Acute Toxic Class method (BASF SE, 2105), doses of 2000 and 300 mg/kg bw of the test item 1,3,5-Benzenetricarboxylic acid, copper(2+) salt (preparations in propylene glycol Ph.Eur.) were administered by gavage to three test groups of three fasted Wistar rats each (2000 mg/kg bw in 3 females and 300 mg/kg bw in 6 females).

Acute oral toxicity testing showed mortalities of 3/3 animals at 2000 mg/kg bw and 0/6 animals at 300 mg/kg bw, therefore the acute oral LD50 value (rat) was calculated to be 300 < LD50 < 2000 mg/kg bw.


Justification for selection of acute toxicity – oral endpoint
GLP- and guideline-conformant study

Justification for classification or non-classification

With 300 < LD50 < 2000 mg/kg bw for 1,3,5-Benzenetricarboxylic acid, according to Regulation (EC) 1272/2008 (CLP), classification as "harmful if swallowed" (Cat. 4, H302) is warranted.