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Administrative data

Description of key information

Acute oral LD50s in both, males and female rats, > 300 and < 2000 mg/kg bw. 
Acute dermal LD50 male/female >2000 mg/kg bw
Acute respiratory LC50 in male rats > 0.333 mg/L

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: comparable to guideline study
Qualifier:
equivalent or similar to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Version / remarks:
Cited as Directive 84/449/EEC, B.1
Deviations:
yes
Remarks:
; purity not reported
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
; purity not reported
GLP compliance:
no
Remarks:
test was performed prior to GLP-requirement
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen
- Age at study initiation: females 64-72 d; males 51-59 d
- Weight at study initiation: females 141-158 g; males 127-187 g
- Fasting period before study: 16 h; overnight
- Housing: individually Macrolon cage type II
- Diet: ssniff, ad libitum
- Water: ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS: according to guideline
Route of administration:
oral: gavage
Vehicle:
peanut oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 112; 164; 241; 353 and 518 g/ L
- Amount of vehicle (if gavage): 2.15 mL/ kg
Doses:
male: 353, 518, 760, 1116 mg/ kg bw
female: 240, 518, 1116 mg/ kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Statistics:
Probit analysis
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
760 mg/kg bw
Based on:
test mat.
95% CL:
345 - 1 671
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
927 mg/kg bw
Based on:
test mat.
95% CL:
587 - 1 464
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
753 mg/kg bw
Based on:
test mat.
95% CL:
578 - 1 070
Mortality:
Male
353 mg/ kg : 0/5
518 mg/ kg : 1/5 day 3 p.a.
760 mg/ kg : 2/5 day 2 and 3 p.a.
1116 mg/ kg : 4/5 day 2 and 3 p.a.

Female
240 mg/ kg : 0/5
518 mg/ kg : 2/5 day 2 and 3 p.a.
1116 mg/ kg : 4/5 day 2 and 3 p.a.
Clinical signs:
ataxia, decrease of muscle tone, loss of reflexes, strenuous respiration, lacrimation, decrease of salivation, piloerection
Gross pathology:
highest dose group: red coloured fluid in the stomach (all animals), brightening of liver (1 animal)
Other findings:
Signs of toxicity occurred as early as 5 min p.a. and were evident until 4 days p.a. in the surviving animals. Deaths occurred on day 2 or 3 p.a.
Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
The test substance caused death under the conditions tested. The LD50 is considered to be 753 mg/kg bw males/females as well as for females alone. Predominant clinical signs observed were ataxia, decrease of muscle tone, loss of reflexes, strenuous respiration, lacrimation, decrease of salivation, piloerection which were present 5 min p.a. and remaind by day 4 p.a.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
753 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-Guideline study
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rabbit
Strain:
other: White Russian
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: White Russian
- Age at study initiation: males 7-12 months, females 7-8 months
- Weight at study initiation: males: 2.48-2.67 kg, females 2.52 - 2.71 kg
- Fasting period before study: 16 h (overnight)
- Housing: individually, stainless steel cages with grating floor type ASTA, size: 48.5x40x36.5 xm supplied by ASTA Pharma AG
- Diet: Standard diet ssniff K; approx. 120 g/ day x animal
- Water: tap water, ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS: according to guideline
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: between shoulder and sacral region
- % coverage: not reported
- Type of wrap if used: occlusive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with tap water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/ kg bw, application was warmed up to 30 C to lower viscosity
Duration of exposure:
24 h
Doses:
2000 mg/kg
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: continuous observation for signs of toxicity the first 4 to 6 h p.a., then once daily; body weights were recorded at the beginning and also 7 d and 14 d p.a.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
Limit test
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occured.
Clinical signs:
3 males showed piloerection on the first 3 days after application, no other symptoms.
Body weight:
2 females showed a slight decreased body weight
Gross pathology:
At necropsy no findings.
Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw

Additional information

Acute oral administration of triallyl cyanurate to rats showed a moderate substance-related effect with LD50s in both, males and females, > 300 and < 2000 mg/kg bw.

No acute dermal toxicity was detected after 24h of exposure. This could be indicative of negligible bioavailability via this route of exposure.

Regarding acute inhalation toxicity, only data on 1h of exposure are available. Exposure to saturated vapour containing triallyl cyanurate (nominal concentration of 0.333 mg/L) did not lead to substance related mortality.


Justification for selection of acute toxicity – oral endpoint
Most valid study available.

Justification for selection of acute toxicity – dermal endpoint
Most valid study available.

Justification for classification or non-classification

GHS: Acute toxicity Category 4. Warning. H302: Harmful if swallowed.