Reaction mass of 1,1-bis(phenethyloxy)ethane and [2-(1-ethoxyethoxy)ethyl]benzene

Endpoint summary

Description of key information

Oral LD50 is >5000 mg/kg bw

Dermal LD50 is >5000 mg/kg bw

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

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Specific details on test material used for the study:

- Description: Clear liquid

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 200 to 300 g
- Fasting period before study: Approx. 18 hours prior to the administration of the test material
- Diet: ad libitum
- Water: ad libitum

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Examinations performed: mortality, toxicity, pharmacological effects, gross pathology (rats who died were examined for visually observable abnormalities of external structures and viscera)

Key result

Sex:

male

Dose descriptor:

discriminating dose

Effect level:

5 000 mg/kg bw

Based on:

test mat.

Mortality:

One animal died on day 13

Clinical signs:

other: None

Gross pathology:

Mottled liver, dark lungs, small intestines, and a red stomach was observed in the animal which died

Interpretation of results:

GHS criteria not met

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

5 000 mg/kg bw

Quality of whole database:

One Klimisch 2 study available. Performed similar to guideline.

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:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Specific details on test material used for the study:

- Description: Clear liquid

Species:

rabbit

Strain:

New Zealand White

Sex:

not specified

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Type of wrap if used: The area was covered with gauze and the trunk wrapped with impervious material
- Epidermal abrasions were made longitudinally every 2-3 cm over the exposed area. The abrasions were sufficiently deep to penetrate the stratum corneum but not deep enough to produce bleeding.

REMOVAL OF TEST SUBSTANCE
- Washing: Yes
- Time after start of exposure: 24 hours

Duration of exposure:

24 hours

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Examinations performed: mortality, clinical signs, skin reactions (Draize), gross pathology for the animals which died

Key result

Sex:

not specified

Dose descriptor:

discriminating dose

Effect level:

5 000 mg/kg bw

Based on:

test mat.

Mortality:

One animal died on day 10.

Clinical signs:

other: Lethargy and loss of coordination was observed in one animal

Gross pathology:

Bloated intestines and mottled liver was observed in the animal which died

Other findings:

Skin reactions on day 1
- Erythema: 7 animals had a score of 3 and two had a score of 1
- Edema: 1 animals had a score of 3; 3 animals had a score of 2; 4 had a score of 1; 2 had a score of 0

Interpretation of results:

GHS criteria not met

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

One Klimisch 2 study available. Performed similar to guideline.

Additional information

Acute oral toxicity:

In an acute oral toxicity study performed similar to OECD 401 (except body weight determination), the test substance was administered via oral gavage to ten male Wistar rats. The concentration administered was 5000 mg/kg bw and the animals were observed for 14 days. One animals died on day 13. No adverse effects were observed. One animal showed mottled liver, dark lungs, small intestines, and a red stomach. The LD50 was determined to be >5000 mg/kg bw.

Acute dermal:

In an acute dermal toxicity study performed similar to OECD 402, the test substance was administered dermally under occlusive conditions to ten New Zealand White rabbits. The concentration applied was 5000 mg/kg bw and the animals were observed for 14 days. Abrasions were made longitudinally every 2-3 cm over the exposed area. The abrasions were sufficiently deep to penetrate the stratum corneum but not deep enough to produce bleeding. One animal died on day 10. The only adverse effect observed was loss of coordination in one animal. Bloated intestines and mottled liver was observed in the animal which died. The LD50 was determined to be >5000 mg/kg bw.

Justification for classification or non-classification

The test substance does not have to be classified for acute oral or dermal toxicity according to Regulation (EC) No 1272/2008.