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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
29 September 2009 - 13 October 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study has been performed according to EC and/or OECD guidelines and in compliance with GLP principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
1,4-Benzenedicarboxylic acid, dimethyl ester, manuf. of, by-products from
EC Number:
273-521-6
EC Name:
1,4-Benzenedicarboxylic acid, dimethyl ester, manuf. of, by-products from
Cas Number:
68988-22-7
Molecular formula:
Molecular formula, molecular weight range, SMILES notation, InChi and structural formula are not available, because DMT byproducts (CAS # 68988-22-7) is a UVCB subsance.
IUPAC Name:
1,4-Benzenedicarboxylic acid, dimethyl ester, manuf. of, by-products from
Details on test material:
- Name of test material (as cited in study report): Terate® 091 Residue
- Substance type: Dark brown solid with soft lumps
- Physical state: Solid
- Analytical purity: 100%
- Composition of test material, percentage of components: by-product from the manufacture of 1,4-Benzenedicarboxylic acid, dimethyl ester
- Lot/batch No.: NB8322-091
- Expiration date of the lot/batch: 14 July 2010
- Stability under test conditions: Not indicated
- Storage condition of test material: At room temperature in the dark

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Strain: Rat, Wistar strain, Crl:WI (Han)
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: approx. 10 weeks old
- Weight at study initiation: mean: 262 gram formales and 204 gram for females
- Fasting period before study: not applicable
- Housing: Individually housed in labeled Macrolon cages containing sterilized sawdust as bedding material and paper as cage-enrichment
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days before start of treatment under laboratory conditions and group housed.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.8 - 21.5ºC
- Humidity (%): 31 - 77%
- Air changes (per hr): approximately 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 29 September 2009 To: 13 October 2009

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: Ethyl acetate (maximum 20% of total volume) and propylene glycol.
Details on dermal exposure:
TEST SITE
- Area of exposure: approx. 25 cm² for males and 18 cm² for females (ie approx. 10% of the total body surface).
- % coverage: 100%
- Type of wrap if used: a surgical gauze patch (Surgy 1D), successively covered with aluminum 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): using tap water
- Time after start of exposure: 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg body weight
- Concentration (if solution): 200 mg/mL
- Constant volume or concentration used: yes, constant concentration


VEHICLE
- Amount(s) applied (volume or weight with unit): 10 mL/kg
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality/Viability: Twice daily.
Body weights: Days 1 (pre-administration), 8 and 15.
Clinical signs: At periodic intervals on the day of dosing (Day 1) and once daily thereafter, until Day 15.
- Necropsy of survivors performed: yes
Statistics:
No statistical analysis was performed.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality occurred.
Clinical signs:
other: Flat posture, chromodacryorrhoea, and/or ptosis were noted in the majority of animals, which had completely recovered from these symptoms by between Days 2 and 3. Brown staining of the treated skin-area of all animals was observed during the observation p
Gross pathology:
No abnormalities were found at macroscopic post mortem examination of the animals.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The dermal LD50 value of Terate® 091 Residue in Wistar rats was established to exceed 2000 mg/kg body weight.
Based on these results, Terate® 091 Residue does not have to be classified and has no obligatory labeling requirement for acute dermal toxicity according to the:
-Regulation (EC) No 1272/2008 on classification, labeling and packaging of substances and mixtures,
-EC criteria for classification and labeling of dangerous substances and preparations (Council Directive 67/548/EEC and all adaptations to technical progress and amendments of this Directive published in the Official Journal of the European Union),
-Globally Harmonized System of Classification and Labeling of Chemicals (GHS) of the United Nations (2007).
Executive summary:

Acute dermal toxicity of the test substance was determined in a guideline study (OECD TG 402) in rats. The dermal LD50 value exceeded 2000 mg/kg body weight.