1,6-Bis(methoxybenzoyloxy)hexane

Endpoint summary

Description of key information

The oral LD50 value of 1070 GA 051 in Wistar rats was established to exceed 2000mg/kg body weight.
Based on these results and according to EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in commission Directive 93/21/EEC), 1070 GA 051 does not have to be classified and has no obligatory labelling requirement for oral toxicity.
The dermal value of Setafix X 11 342 in Wistar rats was established to exceed 2000 mg/kg body weight. Based on these results and according to the: - OECD Harmonized Integrated Hazard Classification System for Human Health and Environmental Effects of Chemical Substances (OECD, 1998), Setafix X 1 1342 does not have to be classified for acute toxicity by the dermal route. - EC criteria for classification and labelling requirements for dangerous substances and preparations (Council Directive 671548lEEC), Setafix X 11 342 does not have to be classified and has no obligatory labelling requirement for dermal toxicity.

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:

06/07/2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study according to OECD test method and to GLP standards

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: approx 8 weeks old
- Weight at study initiation: +/- 20% of the sex mean (Mean of 190g for females, 303g for males on Day 1)
- Fasting period before study: Overnight, maximum of 20 hours prior to dosing until approx 3-4 hours after administration of the test substance.
- Housing: 3 animals per sex per cage in labelled polycarbonate cages containing purified sawdust as bedding material.
- Diet (e.g. ad libitum): Free access to standard pelletd laboratory animal diet (from Carfil Quality BVBA, Oud-Turnhout, Belgium)
- Water (e.g. ad libitum): Free access to tap water.
- Acclimation period: 5 days before start of treatment

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21Centigarde
- Humidity (%): 50% relative
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light and 12 hours dark per day.

Route of administration:

oral: gavage

Vehicle:

propylene glycol

Remarks:

SG 1.036

Details on oral exposure:

Maximum dose volume applied: 2000mg/kg

Doses:

Single dose on day one. 2000mg/kg (10ml/kg) body weight

No. of animals per sex per dose:

1 group of 3 males and 1 group of 3 females, all with the same 2000mg/kg dose.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: Twice daily for mortaility/viability and Body weights on days 1, 8 and 15
- Necropsy of survivors performed: Yes
- Other examinations performed: clinical signs, body weight and macroscopic findings

Statistics:

No statistical analysis was performed.

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No Mortality occured

Clinical signs:

other: No clinical signs were noted

Other findings:

Macroscopic findings: No abnormalities were found at macroscopic post mortem examination of the animals

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The oral LD50 value of 1070 GA 051 in Wistar rats was established to exceed 2000mg/kg body weight.
Based on these results and according to EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in commision Directive 93/21/EEC), 1070 GA 051 does not have to be classified and has no obligatory labelling requirement for oral toxicity.

Executive summary:

The oral LD50 value of 1070 GA 051 in Wistar rats was established to exceed 2000mg/kg body weight.

Based on these results and according to EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in commision Directive 93/21/EEC), 1070 GA 051 does not have to be classified and has no obligatory labelling requirement for oral toxicity.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size

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:

March 2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Using OECD and EC Commission guideline methods and conducted to GLP standards.

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Remarks:

Used a single dose level instead of multiple levels

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

5 females and 5 males (females were nulliparous and non-pregnant).

TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: Approx 8 weeks
- Weight at study initiation: Body weight variations did not exceed +/-20% of the sex mean (Mean on day 1 274g for males, 195g for females)
- Housing: Individually housed in labelled Macrolon cages (type III, height 15cm) containing purified sawdust as bedding material (woody clean type 3/4; Tecnilab_BMI BV, Someren, the Netherlands)
- Diet (e.g. ad libitum):Free acccess to standard pelleted laboratory animal diet (from Altromin (code VRF 1), Lage, Germany).
- Water (e.g. ad libitum): Free access to tap water.
- Acclimation period: Acclimatisation period was at least 5 days before start of treatment under laboratory conditions.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0+/-3.0C
- Humidity (%): 30-70% relative
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark

Type of coverage:

occlusive

Vehicle:

propylene glycol

Details on dermal exposure:

TEST SITE
- Area of exposure: approx 25cm2 for males and 18cm2 for females.
- % coverage: approx 10% of total body surface area
- Type of wrap if used: Formulation was held in contact with skin with a dressing consisting of a surgical gauze patch (Surgy 1D) usccesively covered with aluminium foil and Coban elastic bandage. A piece of micropore tape was additionally used for fixation of the bandages in females only.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Skin cleansed of residual test substance using water.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000mg/L in Propylene glycol
- Constant volume or concentration used: yes

Duration of exposure:

24 hours

Doses:

single dosage on Day 1

No. of animals per sex per dose:

5 females and 5 males (females were nulliparous and non-pregnant).

Control animals:

no

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: Twice daily observations
- Necropsy of survivors performed: yes
- Other examinations performed: Clinical Signs, Body Weight, Macroscopic Findings

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

95% CL:

> 95

Mortality:

No mortality occured

Clinical signs:

other: Clinical Signs Lethargy, hunchedlflat posture andlor chromodacryorrhoea, were noted in the majority of animals between days 1 and 6. In addition, diarrhoea and ptosis were seen in some males on days 1 or 2. Also, erythema (focal, maculate or general), sca

Other findings:

Macroscopic Findings
Enlargement of the mandibular lymph nodes (uni- or bilateral) was noted in two males and two females.
No further abnormalities were found at macroscopic post mortem examination of the animals

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information: Dermal LD50 value of Setafix X 11 342 in Wistar rats was established to exceed 2000 mglkg body weight.

Conclusions:

The dermal value of Setafix X 11 342 in Wistar rats was established to exceed 2000 mg/kg body weight.
Based on these results and according to the:
- OECD Harmonized Integrated Hazard Classification System for Human Health and Environmental Effects of Chemical Substances (OECD, 1998), Setafix X 1 1342 does not have to be classified for acute toxicity by the dermal route.
- EC criteria for classification and labelling requirements for dangerous substances and preparations (Council Directive 671548lEEC), Setafix X 11 342 does not have to be classified and has no obligatory labelling requirement for dermal toxicity.

Executive summary:

The dermal value of Setafix X 11 342 in Wistar rats was established to exceed 2000 mg/kg body weight. Based on these results and according to the: - OECD Harmonized Integrated Hazard Classification System for Human Health and Environmental Effects of Chemical Substances (OECD, 1998), Setafix X 1 1342 does not have to be classified for acute toxicity by the dermal route. - EC criteria for classification and labelling requirements for dangerous substances and preparations (Council Directive 671548lEEC), Setafix X 11 342 does not have to be classified and has no obligatory labelling requirement for dermal toxicity.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

Justification for selection of acute toxicity – oral endpoint
The oral LD50 value of 1070 GA 051 in Wistar rats was established to exceed 2000mg/kg body weight.
Based on these results and according to EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in commission Directive 93/21/EEC), 1070 GA 051 does not have to be classified and has no obligatory labelling requirement for oral toxicity.

Justification for selection of acute toxicity – inhalation endpoint
Inhalation study is only required if exposure is likely to occur or if a dermal tox study is NOT available.
Exposure is not expected to occur during normal intended use and robust study summaries with a Klimisch 1 rating for both Dermal and Oral toxicity are available for this substance. Therefore there is no need to run this study.

Justification for selection of acute toxicity – dermal endpoint
The dermal value of Setafix X 11 342 in Wistar rats was established to exceed 2000 mg/kg body weight. Based on these results and according to the: - OECD Harmonized Integrated Hazard Classification System for Human Health and Environmental Effects of Chemical Substances (OECD, 1998), Setafix X 1 1342 does not have to be classified for acute toxicity by the dermal route. - EC criteria for classification and labelling requirements for dangerous substances and preparations (Council Directive 671548lEEC), Setafix X 11 342 does not have to be classified and has no obligatory labelling requirement for dermal toxicity.

Justification for classification or non-classification

The oral LD50 value of 1070 GA 051 in Wistar rats was established to exceed 2000mg/kg body weight.

Based on these results and according to EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in commission Directive 93/21/EEC), 1070 GA 051 does not have to be classified and has no obligatory labelling requirement for oral toxicity.

The dermal value of Setafix X 11 342 in Wistar rats was established to exceed 2000 mg/kg body weight. Based on these results and according to the: - OECD Harmonized Integrated Hazard Classification System for Human Health and Environmental Effects of Chemical Substances (OECD, 1998), Setafix X 1 1342 does not have to be classified for acute toxicity by the dermal route. - EC criteria for classification and labelling requirements for dangerous substances and preparations (Council Directive 671548lEEC), Setafix X 11 342 does not have to be classified and has no obligatory labelling requirement for dermal toxicity.