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EC number: 210-038-1 | CAS number: 603-40-7
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 26 November 2009 to 30 December 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Version / remarks:
- 2001
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Version / remarks:
- No. 440/2008
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Source of test material:
Sponsor (identification DATIPH)
- Description: brown solid lumps 09 November 2009
- Date received: 09 November 2009
- Storage conditions: approximately 4°C in the dark
The integrity of supplied data relating to the identity, purity and stability of the test material is the responsibility of the Sponsor.
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: For the purpose of the study the test material was freshly prepared, as required, as a suspension in arachis oil BP. Arachis oil BP was used because the test material did not dissolve/suspend in distilled water.
- Determination by analysis of the concentration, homogeneity and stability of the test material preparations was not appropriate because it was not specified in the Study Plan and is nota requirement of the Test Guideline. - Species:
- rat
- Strain:
- Wistar
- Remarks:
- HsdRccHan®™:WIST®™
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: HsdRccHan®™:WIST®™
- Females nulliparous and non-pregnant: yes
- Age at study initiation: eight to twelve weeks old
- Weight at study initiation:
- Fasting period: overnight fast immediately before dosing and for approximately three to four hours after dosing
- Housing: groups of up to four in suspended solid-floor polypropylene cages furnished with woodflakes
- Diet (ad libitum): 2014 Teklad Global Rodent diet supplied by Harlan Teklad, Blackthorn, Bicester, Oxon, UK
- Water (ad libitum): 2014 Teklad Global Rodent diet supplied by Harlan Teklad, Blackthorn, Bicester, Oxon, UK
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 30 to 70%
- Air changes (per hr): at least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): twelve hours continuous light (06:00 to 18:00) and twelve hours darkness
- The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 30 and 200mg/mL
- Amount of vehicle (if gavage): 10ml/kg
- Justification for choice of vehicle: Test material was not soluble in water
MAXIMUM DOSE VOLUME APPLIED: 2000mg/kg
- Rationale for the selection of the starting dose: ln the absence of data regarding the toxicity of the test material, 300 mg/kg was chosen as the starting dose
VEHICLE
- The volume administered: calculated according to the fasted bodyweight at the time of dosing for each animal. Treatment was sequential.
- Justification for choice of vehicle: Test material was not soluble in water
- Doses:
- 300mg/kg, 2000mg/kg
- No. of animals per sex per dose:
- 1 (+4 additional animals for the 2000mg/kg dose)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 30min, 1h, 2h, 4h and daily for 14 days. Morbidity and mortality checks were made twice daily. lndividual bodyweights were recorded on Day 0 (the day of dosing) and on Days 7 and 14.
- Necropsy of survivors performed: yes, the animais were killed by cervical dislocation and subjected to gross necropsy. This consisted of an external examination and opening of the abdominal and thoracic cavities.
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: The appearance of any macroscopic abnormalities was recorded. No tissues were retained. - Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There was no mortality.
- Clinical signs:
- At dose level of 300mg/kg, no signs of systemic toxicity were noted during the observation period.
At dose level of 2000mg/kg, signs of systemic toxicity noted in one animal were hunched posture, ataxia and exophthalmos. No other signs of systemic toxicity were noted (Table 1). - Body weight:
- At dose level of 300mg/kg, the animal showed expected gains in bodyweight over the observation period.
At dose level of 2000mg/kg, animals showed expected gains in bodyweight except for two animals which showed bodyweight loss or no gain in bodyweight during the first week but expected gain in bodyweight during the second week. - Other findings:
- No abnormalities were noted at necropsy.
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- The acute oral median lethal dose (LD50) of the test material in the female Wistar strain rat is estimated to be greater than 2000 mg/kg bodyweight (Globally Harmonised Classification System - Category 5).
- Executive summary:
The study was performed to assess the acute oral toxicity of the 4,4'-Benzylidenedianiline in the Wistar strain rat according to the OECD guideline 420 and method B1 bis of the Commission Regulation (EC) No. 440/2008. 4,4'-Benzylidenedianiline was administered at doses of 300mg/kg and 2000mg/kg. Signs of systemic toxicity noted in one animal treated at a dose level of 2000 mg/kg were hunched posture, ataxia and exophthalmos. No other signs of systemic toxicity or anormalities at the autopsy were noted and there were no deaths. The acute oral median lethal dose (LD50) of the test material in the female Wistar strain rat is estimated to be greater than 2000 mg/kg bodyweight (Globally Harmonised Classification System - Category 5).
Reference
Table 1. lndividual Clinical Observations and Mortality Data
Dose Levelmg/kg |
AnimalNumber and Sex |
Effects Noted After Dosing (Hours) |
Effects Noted During Period After Dosing (Days) |
||||||||||||||||
0.5 |
1 |
2 |
4 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||
2000 |
2-0 Female |
0 |
0 |
0 |
HAB |
HAB |
H |
H |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3-0 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3-1 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3-2 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3-3 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
300 | 1 -0 Female |
0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
0 = No signs of systemic toxicity; H = Hunched posture; A= Ataxia; B=Exophthalamos
Table 2. lndividual Bodyweights and Bodyweight Changes
Dose Level mg/kg |
Animal Number and Sex |
Bodyweight (g) at Day |
Bodyweight Gain (g) During Week |
|||
0 |
7 |
14 |
1 |
2 |
||
2000 |
2-0 Female |
160 |
161 |
180 |
1 |
19 |
3-0 Female |
177 |
178 |
186 |
1 |
8 |
|
3-1 Female |
161 |
160 |
166 |
-1 |
6 |
|
3-2 Female |
176 |
176 |
186 |
0 |
10 |
|
3-3 Female |
185 |
186 |
189 |
1 |
3 |
|
300 |
1-0 Female |
175 |
186 |
196 |
11 |
10 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- Klimisch score 1 (OECD TG 420 & GLP)
Additional information
Justification for classification or non-classification
With oral LD50 > 2000 mg/kg, the test item is not classified for Acute toxicity hazard according to CLP criteria.
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