[No public or meaningful name is available]

Endpoint summary

Description of key information

The acute oral toxicity of technical diphenyl cresyl phosphate based on reliable acute toxicity studies is low.
In an acute oral toxicity test in 10 male and female Wistar rats the LD50 was greater than 5000 mg/kg bw. The decrease of general condition was the only symptom that could be seen (Loeser, 1982).
Acute toxicological investigations of male and female Wistar rats were conducted after dermal exposure of diphenyl cresyl phosphate (Disflamoll DPK). After administration of 2000 mg/kg bw no local signs and no clinical signs were observed; also the body weight development of male and female rats was not affected. No animal died and the animals sacrificed at the end of study showed no noticeable gross pathological findings. The LD50 was estimated to be greater than 2000 mg/ kg and was not exactly determined (Krötlinger, 1999).
Additional studies are discussed by MAK 2003 or BG Chemie 2000 (no. 195). Overall the available data are consistent with the key studies, indicating that the test substance has low acute toxicity.
There are no data on acute inhalation toxicity available.

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:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Principles of method if other than guideline:

Five male and five female rats received a single dose of 3.1 or 5 ml Disflamoll DPK/kg bw by gavage. The animals were observed for mortality, clinical signs, and body weight. A gross pathological examination of the surviving rats was conducted randomly.

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Animals were housed in groups of 5 animals conventional in Macrolon cages type III on dust free wood granules at a temperature of 22+/- 1.5°C. Light/dark rythmus was 12 hours. and air humidity 60 +/- 55

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

5.0 ml/kg; 3.1 ml/kg bw.

No. of animals per sex per dose:

5/sex/dose

Control animals:

not specified

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mL/kg bw

Mortality:

1 male animal died at a dose of 5 ml/kg bw.

Clinical signs:

other: Decreased general condition.

Gross pathology:

No findings.

Dose (ml/kg bw)	Sex	Mortality	No of animals	Animals with symtoms	start of symtoms	decrease of general condition
5,0	male	1	5	5	after 10 hours	yes
5,0	female	0	5	5	after 10 hours	yes

Interpretation of results:

GHS criteria not met

Executive summary:

In an acute oral toxicity test in 10 male and female Wistar rats the LD50 was >5000 ml/kg bw (5000 ml/kg bw = 6050 mg/kg bw; density = 1.21 mg/µg).

The decrease of general condition was the only symptom that was seen.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

5 000 mg/kg bw

Quality of whole database:

Scientifically acceptable and sufficient documented for evaluation.

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:

guideline study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

the number of animals and the procedure of dose finding were done with reference to OECD Guideline 423 due to animal welfare reasons.

Principles of method if other than guideline:

Three male and three female rats received a single dermal dose of 2000 mg Disflamoll DPK/kg bw. The animals were observed for mortality, clinical signs, and body weight during a 14 day period. A gross pathological examination was done on all animals at the end of the study.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

The mean initial weight of males was 268 g and of females 213 g.

Type of coverage:

other: non irritant skin plaster

Vehicle:

unchanged (no vehicle)

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3/sex/dose

Control animals:

not required

Key result

Sex:

male/female

Dose descriptor:

discriminating dose

Effect level:

2 000 mg/kg bw

Mortality:

no

Clinical signs:

other: no

Gross pathology:

no noticeable findings

Other findings:

no data

After administration of 2000 mg/kg bw no local signs and no clinical signs were observed; also the body weight development of male and female rats was not affected. No animal died and the animals sacrificed at the end of study showed no noticeable gross pathological findings. The LD50 was estimated to be greater than 2000 mg/ kg and was not exactly determined.

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 was estimated to be greater than 2000 mg/kg and was not exactly determined.

Executive summary:

Acute toxicological investigations of male and female Wistar rats were conducted after dermal exposure of Diphenylkresylphosphate (Disflamoll DPK). After administration of 2000 mg/kg bw no local signs and no clinical signs were observed; also the body weight development of male and female rats was not affected.

No animal died and the animals sacrificed at the end of study showed no noticeable gross pathological findings.

The LD50 was estimated to be greater than 2000 mg/kg and was not exactly determined.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Quality of whole database:

Guideline study.

Justification for classification or non-classification

The acute oral toxicity in rats is > 5000 mg/kg bw and the acute dermal toxicity in rats is > 2000 mg/kg bw. No reliable acute toxicity study by the inhalation route is available.

According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.