1,6-Bis(methoxybenzoyloxy)hexane

Acute Toxicity: dermal

Administrative data

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.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

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

Test material

Test material information

Constituent 1

Reference substance name:

SETAFIX X 11342

IUPAC Name:

SETAFIX X 11342

Test material form:

solid: crystalline

Details on test material:

- Name of test material (as cited in study report): SETAFIX X 11342
- Molecular formula (if other than submission substance): C22H26O6
- Molecular weight (if other than submission substance): 386g/mol
- Substance type: Light Yellowish Solid
- Physical state: Solid
- Analytical purity: >95% resin
- Lot/batch No.: PP03
- Expiration date of the lot/batch: 31st December 2004

Test animals

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

Administration / exposure

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

Results and discussion

Effect levels

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

Applicant's summary and conclusion

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.