Registration Dossier

Administrative data

Description of key information

Oral and dermal acute toxicity are all considered.

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:
September 29 1982 to January 25 1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non GLP, carried out according to recognised (older) guideline, results fully documented. Considered appropriate for use based on data available and animal welfare concerns.
Reason / purpose:
reference to same study
Qualifier:
according to
Guideline:
other: Consistent with Environmental Protection Agency's Guidelines for registering pesticides in the U.S.: Hazard evaluation: Humans and Domestic Animals, Fed. Reg. 43:163 37336-37402 (1978). and OECD Guidelines (1981)
Deviations:
no
Principles of method if other than guideline:
Sprague-Dawley albino rats were used for test purposes. The test material was either dissolved or suspended in a suitable vehicle. The test material was administered in single doses by means of the gavage tube. A minimum of ten animals were used for each dose level. The animals were fasted for 16-18 hours prior to treatment. The animals were observed for at least 14 days after treatment for mortality and signs of toxicity. Necropsies were performed on all animals that died during the study (with the exception of cannabalized animals) and on all survivors.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Animals used in this study were purchased from Charles River laboratories, Portage, Michigan. No details on environmental conditions are provided.
Males, Weight Range, grams: 182-214
Females, Weight Range, grams: 142-179
Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
The test material was administered in single doses by means of the gavage tube. A minimum of ten animals were used for each dose level. The animals were fasted for 16-18 hours prior to treatment.
Doses:
5000 mg/kg
No. of animals per sex per dose:
10
Control animals:
yes
Details on study design:
Sprague-Dawley albino rats were used for test purposes. The test material was either dissolved or suspended in a suitable vehicle. The test material was administered in single doses by means of the gavage tube. A minimum of ten animals were used for each dose level. The animals were fasted for 16-18 hours prior to treatment. The animals were observed for at least 14 days after treatment for mortality and signs of toxicity. Necropsies were performed on all animals that died during the study (with the exception of cannabalized animals) and on all survivors.
Statistics:
None reported.
Preliminary study:
Not applicable.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
0/10 per sex
Clinical signs:
Males: A single dose of 5000 mg/kg produced no mortalities. Adverse clinical signs for all rats included mild depression, piloerection, wet fur, diarrhea, yellowish anogenital stains, evidence of excessive urination, and red facial stains. All rats appeared normal by day 7.

Females: A single dose of 5000 mg/kg produced no mortalities. Adverse clinical signs for all rats included mild to moderate depression, piloerection, ataxia, evidence of excessive urination, and red-stained muzzles. All rats appeared normal on day 6.
Body weight:
Not reported.
Gross pathology:
All rats were necropsied following termination on Day 14 and appeared normal.
Other findings:
None
Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral LD50 for Fyrquel EHC (Trixylenyl Phosphate) given to male albino rats was >5000 mg/kg. Commonly observed adverse clinical signs included depression, piloerection, wet fur, diarrhea, yellow anogenital stains, evidence of excessive urination, and red facial stains. All rats
appeared normal at necropsy.
The acute oral LD50 for Fyrquel EHC (Trixylenyl Phosphate) given to female albino rats was >5000 mg/kg. Commonly observed adverse clinical signs included depressions piloerection, ataxia, evidence of excessive urination, and red-stained muzzles. All rats appeared normal at necropsy.
Executive summary:

The acute oral LD50 for male and female albino rats was > 5000 mg/kg body weight. Commonly observed adverse clinical signs included: Mild to moderate depression, piloerection, ataxia (female rats only), wet fur (male rats only), diarrhea (male rats only), yellowish anogenital stains (male rats only), evidence of excessive urination and red facial stains. All rats appeared normal at necropsy.

The substance is not classified on the basis of the results.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
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
Study period:
September 29 1982 to January 25 1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non GLP, carried out according to recognised (older) guideline, results fully documented. Considered appropriate for use based on data available and animal welfare concerns.
Reason / purpose:
reference to same study
Qualifier:
according to
Guideline:
other: Consistent with Environmental Protection Agency's Guidelines for registering pesticides in the U.S.: Hazard evaluation: Humans and Domestic Animals, Fed. Reg. 43:163 37336-37402 (1978); test exceeds the protocol recommended in the OECD Guidelines (1981)
Deviations:
no
Principles of method if other than guideline:
Stauffland albino rabbits were used in this study. A minimum of four male and four female rabbits had the test material applied to the closely clipped abdominal skin beneath a protective binder. The skin was abraded on half the animals and left intact on the others. After a 24 hour period, the binder material and test material were removed, the abdominal skin was inspected for irritation and rewrapped in a gauze binder. Three days later this gauze binder was removed. The test animals were observed for at least 14 days following the initial treatment. Necropsies were performed on all animals that died during the study and all survivors.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rabbit
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
Animals used for this study were purchased from Phillips Rabbitry, Soquel, California.
Weight Range, kg: 1.550-2.038
No information on environmental conditions is provided.
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
A minimum of four male and four female rabbits had the test material applied to the closely clipped abdominal skin beneath a protective binder. The skin was abraded on half the animals and left intact on the others. After a 24 hour period, the binder material and test material were removed, the abdominal skin was inspected for irritation and rewrapped in a gauze binder. Three days later this gauze binder was removed.
Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
4
Control animals:
yes
Details on study design:
Stauffland albino rabbits were used in this study. A minimum of four male and four female rabbits had the test material applied to the closely clipped abdominal skin beneath a protective binder. The skin was abraded on half the animals and left intact on the others. After a 24 hour period, the binder material and test material were removed, the abdominal skin was inspected for irritation and rewrapped in a gauze binder. Three days later this gauze binder was removed. The test animals were observed for at least 14 days following the initial treatment. Necropsies were performed on all animals that died during the study and all survivors.
Statistics:
None reported.
Preliminary study:
Not applicable.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Mortality: 0/10
Clinical signs:
The rabbits appeared normal throughout the test. Local dermal effects included mild erythema and edema following 24 hour exposure.
Body weight:
Not reported.
Gross pathology:
Ten rabbits were necropsied following termination on day 14 and appeared normal.
Interpretation of results:
other:
Remarks:
CLP criteria not met
Conclusions:
The acute dermal LD50 for Fyrquel EHC (Trixylenyl phosphate) given to a mixed population of albino rabbits was >2000 mg/kg. There were no apparent adverse clinical signs. Local dermal effects included mild erythema and edema following a 24 hour exposure. All rabbits appeared normal at necropsy
Executive summary:

The acute dermal LD50 for Fyrquel EHC (Trixylenyl phosphate) given to a mixed population of albino rabbits was >2000 mg/kg. There were no apparent adverse clinical signs. Local dermal effects included mild erythema and edema following a 24 hour exposure. All rabbits appeared normal at necropsy.

The substance is not classified on the basis of the results provided.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Testing on the above endpoints gave the following results:

 

Acute toxicity: Oral.

 

1 main study is available for the derivation of LD50 acute oral toxicity and gave the result as:

LD50: >5000 mg/kg

 

Acute toxicity: Dermal.

 

One main study are presented for this endpoint and gave the result as follows:

 LD 50: >2000 mg/kg

  

Acute toxicity: Inhalation.

No assessment of inhalation exposure on the substance, has been conducted as given the low volatility of the substance and the manner in which it is used, extensive exposure by inhalation is not anticipated. There is the potential for exposure by inhalation from some of the categories of use; however as these are as a result of the substance as a component of a product at low level, plus the fact that PPE during use of such products is recommended, it is considered that exposure by inhalation will not pose a hazard. In addition, the dermal route of exposure is considered more appropriate for exposure to the substance, given the nature and conditions of usage.

Justification for selection of acute toxicity – oral endpoint

Single study available; Non GLP, carried out according to recognised (older) guideline, results fully documented.  Considered appropriate for use based on data available and animal welfare concerns.

Justification for selection of acute toxicity – inhalation endpoint

The test substance has very low vapor pressure and high boiling point, so the potential for the generation of inhalable forms is low, also the use of this substance isn unlikely result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur, and no acute inhalation test was performed. Dermal exposure is considered the appropriate route.

Justification for selection of acute toxicity – dermal endpoint

Single study available; Non GLP, carried out according to recognised (older) guideline, results fully documented.  Considered appropriate for use based on data available and animal welfare concerns.

Justification for classification or non-classification

The above studies have all been ranked reliability 2 according to the Klimish et al system. This ranking was deemed appropriate because the studies were not conducted to GLP or in compliance with agreed protocols. The reports do not detail a specific method; however it documents dose levels and responses in detail, so is deemed appropriate for use in the support of a formal registration. Sufficient dose ranges and numbers are detailed; hence it is appropriate for use based on reliability and animal welfare grounds.

Justification for classification or non classification

The above results triggered no classification under the Dangerous Substance Directive (67/548/EEC) and the CLP Regulation (EC No 1272/2008). No classification for acute effects is therefore required.