Dimethyl (p-methoxybenzylidene)malonate

Endpoint summary

Description of key information

The oral LD50 in rats was > 2000 mg/kg bw in a reliable study (RL1).

There is no study on acute inhalation and dermal 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

Study period:

2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

other: Hanlbm: WIST (SPF)

Sex:

male/female

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Remarks:

PEG 300

Details on oral exposure:

The animals received a single dose of the test item on a 2000 mg/kg body weight basis by oral gavage following fasting for approximately 17 hours, but with free access to water. Food was provided again 3 hours after dosing.
Dose / kg body weight: 2000 mg
Application volume: 10 ml
Rationale: Oral administration was used as this is one possible route of human exposure during manufacture, handling and use of the test item.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 males or 3 females
Total number of animals: 3 males, 3 females
Age when treated: Males & females: 8 - 10 weeks
Body weight range when treated: Males: 230.4 - 258.2 g, Females: 165.1 - 179.3 g

Control animals:

no

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: after single oral administration to rats of both sexes, observed over a period of 14 days

Mortality:

No death occurred during the study.

Clinical signs:

other: Slight ruffled fur was observed in one female animal (no. 1) from 1 to 5 hours after the administration of the test item. Hunched posture was noted additionally in the same female at the 3- and 5-hour observation. No clinical signs were observed during th

Other findings:

Macroscopic findings: No macroscopic findings were observed at necropsy.

Interpretation of results:

other: not classified

Conclusions:

The LD50 of the test substance was determined to be LD50(rat) > 2000 mg/kg body weight.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

The key study is reliable without restrictions

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

other justification

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

no study available

Quality of whole database:

The acute inhalation study was waived in accordance with Annex XI section 1.2: no testing for acute toxicity after inhalations exposure has to be performed because there is sufficient evidence from existing studies that the substance is not acutely toxic/lethal up to the limit doses (e.g. acute oral toxicity study with LD50 > 2000 mg/kg OECD 422 study: LOAEL 1000 mg/kg bw, but no lethality).

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Justification for type of information:

In accordance with column 2 of REACH Annex VIII, 8.5.3. the study does not need to be conducted because
- the substance does not meet the criteria for classification for acute toxicity or STOT SE by the oral route and
- no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation)

Endpoint conclusion

Endpoint conclusion:

no study available

Quality of whole database:

The acute dermal study was waived in accordance with column 2 of REACH Annex VIII, 8.5.3., because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation).

Additional information

In a reliable guidelinestudy in rats an oral LD50 value of > 2000 mg/kg was determined.

The acute inhalation study was waived in accordance with Annex XI section 1.2: no testing for acute toxicity after inhalations exposure has to be performed because there is sufficient evidence from existing studies that the substance is not acutely toxic/lethal up to the limit doses (e.g. acute oral toxicity study with LD50 > 2000 mg/kg OECD 422 study: LOAEL 1000 mg/kg bw, but no lethality.

The acute dermal study was waived in accordance with column 2 of REACH Annex VIII, 8.5.3., because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation).

Justification for classification or non-classification

The submission substance has not to be classified for acute toxic effects according to Regulation (EC) No 1272/2008 (CLP).