3,9-dicyclohex-3-enyl-2,4,8,10-tetraoxaspiro[5.5]undecane

Endpoint summary

Description of key information

A valid acute oral and dermal toxicity study and 2 acute inhalation toxicity studies are available. In the acute inhalation toxicity studies no exact LC50 values were determined.

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:

other: scientifically acceptable and sufficient documented

Principles of method if other than guideline:

Ten male rats received a single dose (2500 or 5000 mg/kg bw) per gavage. The animals were observed for mortality, body weight gain and clinical signs through day 14.

GLP compliance:

no

Test type:

standard acute method

Species:

rat

Strain:

Wistar

Sex:

male

Route of administration:

oral: gavage

Vehicle:

other: Lutrol

Doses:

2500 or 5000 mg/kg bw

No. of animals per sex per dose:

10 male rats per dose

Control animals:

not specified

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

None of the animals which received a dose of 2500 mg/kg bw died and no clinicla signs were observed. One animal our of 10 died which received a dose of 5000 mg/kg bw. The animal died after 2 days. No clinicla signs were observed on the animals which survived.

Signs of intoxication were sedation and a decrease of the general condition.

Interpretation of results:

relatively harmless

Remarks:

Migrated information

Executive summary:

Ten male rats received a single dose (2500 or 5000 mg/kg bw) per gavage. The animals were observed for mortality, body weight gain and clinical signs through day 14.

None of the animals which received a dose of 2500 mg/kg bw died and no clinicla signs were observed. One animal our of 10 died which received a dose of 5000 mg/kg bw. The animal died after 2 days. No clinicla signs were observed on the animals which survived.

Signs of intoxication were sedation and a decrease of the general condition.

The LD50 is > 5000 mg(kg bw (male rats)

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

5 000 mg/kg bw

Quality of whole database:

The materials/methods and results are described sufficient for evaluation

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: No LC50 determined - highest applied dose caused no deaths and no clinical signs

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Principles of method if other than guideline:

The test substance was heated in a 400 liter chamber to 150 °C. Female rats and female mice as well as male hamsters and male rabbits were exposed to the vapours of the test substance for 4 hours. During a post-observation period of 14 days the animals were observed for mortality and clinical signs.

GLP compliance:

no

Test type:

standard acute method

Species:

other: rat, mouse, hamster, rabbit

Strain:

other: Wistar rats; NMRI mice; New Zealand white rabbits

Sex:

male/female

Route of administration:

inhalation: vapour

Type of inhalation exposure:

whole body

Vehicle:

air

Analytical verification of test atmosphere concentrations:

yes

Remarks:

gravimetric analysis of vaporised product

Duration of exposure:

4 h

Concentrations:

6742 mg/m³: mice male
6742 mg/m³: rat, male
8000 mg/m³: hamster
8000 mg/m³: rabbbit

No. of animals per sex per dose:

20 mice, 10 rats, 5 hamsters, and 2 rabbits

Control animals:

no

Sex:

male

Dose descriptor:

LC50

Effect level:

> 6.74 mg/L air

Based on:

test mat.

Exp. duration:

4 h

Remarks on result:

other: rats

Sex:

male

Dose descriptor:

LC50

Effect level:

> 6.74 mg/L air

Based on:

test mat.

Exp. duration:

4 h

Remarks on result:

other: mice

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 8 mg/L air

Based on:

test mat.

Exp. duration:

4 h

Remarks on result:

other: hamsters

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 8 mg/L air

Based on:

test mat.

Exp. duration:

4 h

Remarks on result:

other: rabbits

The test substance was vaporised at 150°C

Executive summary:

The test substance was heated in a 400 liter chamber to 150 °C. Female rats and female mice as well as male hamsters and male rabbits were exposed to the vappours of the test substance for 4 hours. During a post-observation period of 14 days the animals were observed for mortality and clinical signs.

None of the rats and mice died (mortality: 0/10 female rats and 0/20 female mice). A concentration of 6742 mg/m³ was tolerated by the animals without symptoms. None of the hamsters and rabbits died (mortality: 0/5 male + female hamsters and 0/2 male + female rabbits). A concentration of 8000 mg/m³ was tolerated by the animals without symptoms.  

Therefore the LC50 is > 6742 mg/m³ for male rats and mice. The LC50 for male and female hamsters and rabbits is > 8000 mg/m³.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

discriminating conc.

Value:

6 742 mg/m³ air

Quality of whole database:

The materials/methods and results are described sufficient for evaluation

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:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: scientifically acceptable and sufficient documented

Principles of method if other than guideline:

Five male and five female rats received a single dose (1000 or 5000 mg/kg bw) of KAC 4196 as emulsion in cremophor for 24 hours. The animals were observed for mortality, body weight gain and clinical signs through day 7.

GLP compliance:

not specified

Test type:

standard acute method

Species:

rat

Strain:

Wistar

Sex:

male/female

Type of coverage:

not specified

Vehicle:

other: cremophor

Duration of exposure:

24 hours

Doses:

1000 or 5000 mg/kg bw

No. of animals per sex per dose:

5 male and 5 female rats/dose

Control animals:

not specified

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

None of the animals died. The animals dosed with 1000 mg/kg bw were without findings. Animals which were treated with 5000 mg/kg bw revealed a temporary reduced general condition during an observation period of 7 days.

Executive summary:

Five male and five female rats received a single dose (1000 or 5000 mg/kg bw) of KAC 4196 as emulsion in cremophor for 24 hours. The animals were observed for mortality, body weight gain and clinical signs through day 7.

None of the animals died. The animals dosed with 1000 mg/kg bw were without findings. Animals which were treated with 5000 mg/kg bw revealed a temporary reduced general condition during an observation period of 7 days. The LD50 dermal is > 5000 mg/kg bw (m + f rats)

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

5 000 mg/kg bw

Quality of whole database:

The materials/methods and results are described sufficient for evaluation

Additional information

In the acute oral toxicity study 2 groups of 10 male Wister rats (average weight 160-180 g) received per gavage a single dose of 2500 or 5000 mg/kg bw Ozonschutzmittel KAC 4196. The animals were observed for mortality, weight and clinical signs through day 14. None of the animals died.

In the acute dermal toxicity study 2 groups of 5 maleWistar rats were applied 1000 or 5000 mg/kg bw of the undiluted test substance for 24 hours. The animals were exmained for mortality. None of the animals died.

Two studies are available for acute inhalation toxicity. In one study the test substace was applied as vapour in concentrations of 6742 mg/m³ to male rats and mice and 8000 mg/m³ to hamsters and rabbits. In the other one the test substance was applied as dust in concentrations of 283 or 1517 mg/m³ to male and female rats. In both studies the highest applied dose caused not deaths and no characteristic clinical signs.

Justification for selection of acute toxicity – oral endpoint
key study used

Justification for selection of acute toxicity – inhalation endpoint
2 studies are available. In one study the test substace was applied as vapour and in the other one as dust. In both studies the highest applied dose caused not deaths and no (characteristic) clinical signs. In the vapor study rats, mice, hamster and rabbits were exposed to the test substance.

Justification for selection of acute toxicity – dermal endpoint
key study used

Justification for classification or non-classification

Two reliable acute toxicity studies are available. In the acute oral and acute dermal toxicity study the LD50 is > 5000 mg/kg bw.

Therefore a classification is not justified.

In the acute inhalation study where the test substance was applied as dust, the LC50 is > 1517 mg/m³ and in the acute inhalation study where the test substance was applied as vapour, the LC50 is > 6742 mg/m³. Therefore the inhalation studies are not reliable for a classification.