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Administrative data

Description of key information

Oral studies follow a standard acute method or are equivalent or similar to OECD 401.

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:
1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study was conducted prior to GLP and test guidelines, but sufficient data is available for interpretation of results.
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study
Qualifier:
no guideline available
Principles of method if other than guideline:
LD50 study in female rats, 5 rats/dose level.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
not specified
Sex:
female
Details on test animals and environmental conditions:
No data
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
single-dose intubation using calibrated syringe and suitable rubber catheter
Doses:
1.58, 2.0, 2.52, 3.16 or 3.98 g/kg
No. of animals per sex per dose:
5 female rats/dose
Control animals:
no
Details on study design:
Animals subjected to acute oral toxicity studies were fed by single-dose intubation using a calibrated syringe and a suitable rubber catheter. Animals were fasted overnight prior to dosing. Material was administered undiluted. All animals were weighed and observed at intervals over a two-week post-feeding period or until any weight loss is regained and the animals appear healthy. Pathological observation is made on representative animals.
Statistics:
No data
Preliminary study:
Not applicable
Sex:
female
Dose descriptor:
LD50
Effect level:
2.83 other: g/kg
95% CL:
2.49 - 3.21
Mortality:
Mortality: 0/5 for 1.58 g/kg, 0/5 for 2.0 g/kg, 1/5 for 2.52 g/kg, 4/5 for 3.16 g/kg and 5/5 for 3.98 g/kg
Clinical signs:
1st day- Starting at 2.52 g/kg and up, the rats looked sleepy and depressed; 3rd day- rats given 2.52 g/kg had urine soaked hind quarters and rats given 3.16 g/kg were urine soaked and had red nasal discharge
Body weight:
No data
Gross pathology:
No data
Other findings:
None

None

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: United Nations GHS
Conclusions:
The acute oral lethality of the test material is low. The acute oral LD50 in female rats was calculated to be 2830 mg/kg body weight (95% confidence limits 2490-3210 mg/kg).
Executive summary:

A sample of industrial grade diphenyl oxide XA-1075-L, was submitted to Chemical Biology Research for evaluation of acute oral lethality, eye and skin irritation properties, and for definition of industrial handling hazards involving acute exposures. The test material is in the early stages of application development. The objective of this study was to provide initial toxicological information on the industrial grade material. As applications are developed, additional appropriate toxicological tests may be required.

The acute oral lethality of the test material is low. The acute oral LD50 in .female rats was calculated to be 2.83 g/kg body weight (95% Confidence Limits 2.49-3.21 g/kg).* There is little likelihood that internal. injury would result from acute ingestion of amounts of the material one might encounter incidental to industrial handling.

Eye contact with the test material would likely result in very slight pain, very slight transient conjunctival inflammation, and possibly a slight transient corneal injury. Safety glasses are recommended whenever the likelihood of eye contact exists.

Prolonged skin contact with the test material would likely result in slight redness and moderate swelling. However, if contact is repeated and/or contaminated clothing is worn for several days moderate redness, moderate swelling and a moderate chemical burn may result. The test material is not likely to be absorbed

through the skin in acutely toxic amounts. Prolonged and/or repeated skin contact should be avoided. If contact occurs, the skin should be decontaminated with soap and water and contaminated clothing thoroughly cleaned before re-use.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 830 mg/kg bw
Quality of whole database:
acceptable quality

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
Study period:
1977
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Insufficient data on a non-GLP study. However data are consistent with low toxicity observed via oral route and low degree of dermal penetration.
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study
Qualifier:
according to
Guideline:
other: No data
Principles of method if other than guideline:
No data
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24 h
Doses:
3160, 5010 or 7940 mg/kg
No. of animals per sex per dose:
1-2/sex/dose
Control animals:
no
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 7 940 mg/kg bw
Based on:
test mat.
Mortality:
No animals died
Clinical signs:
Signs of Intoxication: Reduced appetite and activity (3 -5 days)
Gross pathology:

Survivors (14 days): Viscera appeared normal

Mortality: 0/1 male at 3160 mg/kg, 0/1 female at 5010 mg/kg and 0/1 male and 0/1 female at 7940 mg/kg

Signs of Intoxication: Reduced appetite and activity (3 -5 days)

Survivors (14 days): Viscera appeared normal

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: United Nations GHS
Conclusions:
The acute dermal toxicity in rabbits is >7940 mg/kg.
Executive summary:

Undiluted Diphenyl Oxide was dermally applied to Sprague-Dawley albino rats at dose levels of 3160, 5010 or 7940 mg/kg. The acute dermal toxicity in rabbits was determined to be >7940 mg/kg.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
7 940 mg/kg bw
Quality of whole database:
acceptable quality

Additional information

Acute Oral: several studies are available for diphenyl oxide (DPO). All studies are of acceptable quality (Klimisch rating 2) and the reported LD50 values are all greater than 2800 mg/kg bw. The LD50 value of 2830 mg/kg bw reported in the key study for female rats is taken for hazard classification considerations.

Acute Dermal: in a minimally reported dermal toxicity study, DPO did not produce any mortalities at doses up to 7940 mg/kg in rabbits. Even though this study has minimal information the results are consistent with the oral toxicity results taking into account the lower bioavailability following dermal application.

Acute inhalation: The low vapour pressure of this material (0.02 mm Hg) and the known use patterns lead to the conclusion that acute inhalation exposures are not considered likely to occur. Also, the acute oral toxicity data indicate this substance has minimal toxicity via the oral route. It is therefore not expected that it will have greater toxicity via the inhalation route.


Justification for selection of acute toxicity – oral endpoint
study with lowest LD50 value reported.

Justification for classification or non-classification

No classifications for acute toxicity are required for DPO.