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Description of key information

The acute oral median lethal dose (LD50 cut- off value) TCPD (Distilled Tricyclopentadiene) in Wistar rats was found to be 5000 mg/kg body weight.

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:
Study Initiation (9 November 2018) to Experimental Completion (22 December 2018)
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
no
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source of test material: Materia, Inc.
- Batch/lot No.of test material: RP229-0714
- Expiration date of the lot/batch: 28 April 2019
- Purity test date: 28 March 2018 (CoA)

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature (ambient). Container kept tightly closed in a dry, cool and well ventilated place. After opening swept with Nitrogen gas an re-sealed.
- Stability under test conditions: Assumed stable for the duration of the test
- Solubility and stability of the test substance in the solvent/vehicle: Formed a homogenous suspension in Corn Oil. Assumed stable for the duration of the study as gavage solutions were prepared fresh prior to dosing on all occasions..
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: None

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Prepared as a homogenous solution in Corn Oil prior to dosing on each occasion.

FORM AS APPLIED IN THE TEST (if different from that of starting material) Prepared as a homogenous solution in Corn Oil prior to dosing on each occasion.

OTHER SPECIFICS:
- measurement of pH, osmolality, and precipitate in the culture medium to which the test chemical is added: Not specified.
- other information: None
Species:
rat
Strain:
Wistar
Remarks:
RccHan : WIST
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Animal Breeding Facility, Jai Research Foundation, India
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 10 to 12 weeks
- Weight at study initiation: Min: 169.1g, Max: 215.9g
- Fasting period before study: Rats were fasted overnight prior to dosing and for three hours post-dose.
- Housing: In polypropylene rat cages covered with a stainless steel grid top. Three rats per cage
- Diet (e.g. ad libitum): yes (with the exception of the fasting period pre and post dose)
- Water (e.g. ad libitum): yes
- Acclimation period: 5 to 11 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 23°C
- Humidity (%): 57 to 66%
- Air changes (per hr): Minimum of 15 air changes/hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial light and 12 hours darkness, light hours being 06:00 h – 18:00 h (photoperiod maintained through an automatic timer)

IN-LIFE DATES: From: To: 24 November 2018 (Experimental Start) to 22 December 2018 (Experimental Completion)
Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 30 mg and 200 mg in 10 mL Corn Oil dosed at a dose volume of 10 ml/kg bw. i.e. 300 mg/kg bw (for set I and II) and 2000 mg/kg bw (for set III and IV).
- Amount of vehicle (if gavage): 300 mg/kg bw group (1.69 - 2.07 mL), 2000 mg/kg bw group (1.99 - 2.16 mL)
- Justification for choice of vehicle: The test item was insoluble in Reverse Osmosis (RO) water and 0.5% Carboxy methyl Cellulose. However, it formed a homogenous suspension in Corn oil. Dose formulations were therefore prepared using Corn oil as the selected vehicle.
- Supplier: (Sigma Aldrich)
- Lot/batch no. Not specified
- Purity: No specified

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: As no toxicological information was available on the test item, in accordance with OECD 423 a starting dose of 300 mg/kg bw TCPD (Distilled Tricyclopentadiene) was selected as the initial test dose.
Doses:
300 mg/kg bw (for set I and II) and 2000 mg/kg bw (for set III and IV) mg/kg bw.
No. of animals per sex per dose:
6 female rats/group
Control animals:
no
Details on study design:
- Duration of observation period following administration: All rats were observed for 14 days.
- Frequency of observations and weighing: Rats were observed for signs of toxicity and mortality at 0.5, 1, 2, 3, 4 and 6 h post-administration on the day of dosing. Rats were observed twice a day for morbidity and mortality for a period of 14 days following oral dosing. Clinical signs were recorded once a day. Individual body weight was recorded prior to dosing on day 0 and on days 7 and 14.

- Necropsy of survivors performed: yes, at the end of the 14 day observation period, all rats were euthanised by carbon dioxide asphyxiation and subject to gross pathological examination, consisting of external examination and opening of the abdominal and thoracic cavities.
Key result
Sex:
female
Dose descriptor:
LD50 cut-off
Effect level:
>= 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed in any rat treated with 300 or 2000 mg/kg bw TCPD.
Clinical signs:
No clinical signs were observed in any rat treated with 300 or 2000 mg/kg bw TCPD.
Body weight:
Normal gain in body weight was observed in all rats treated with 300 or 2000 mg/kg bw TCPD.
Gross pathology:
Necropsy (Macroscopic Findings)

External examination of terminally sacrificed rats did not reveal any abnormality.
Internal (Visceral examination) of terminally sacrificed rats did not reveal any abnormality.

In absence of any pathological lesion in terminally sacrificed rats, it is concluded that the test item did not produce any treatment related effect at dose levels used in the present study.
Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
The acute oral median lethal dose (LD50 cut- off value) TCPD (Distilled Tricyclopentadiene) in Wistar rats was found to be 5000 mg/kg body weight.

Based on results of this study, the classification for TCPD (Distilled Tricyclopentadiene) is as follows:
Globally Harmonized System of Classification and Labelling of Chemicals (GHS 2017): Category 5 or Unclassified
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw
Quality of whole database:
Klimisch 1

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

The test substance has not been classified as toxic by oral dose as the acute oral median lethal dose (LD50 cut- off value) TCPD (Distilled Tricyclopentadiene) in Wistar rats was found to be 5000 mg/kg body weight.