Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Older study conducted prior to the introduction of GLP and OECD test guidelines. Standard methods used but details of methods and results not available. For read-across justification see Section 13.
Qualifier:
no guideline followed
Principles of method if other than guideline:
Rats given single doses of DUP of up to at least 15, 800 mg/kg bw. Animals observed for signs of toxicity.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
No data
Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
No data
Doses:
Up to at least 15,800 mg/kg bw
No. of animals per sex per dose:
No data
Control animals:
not specified
Details on study design:
No data
Statistics:
No data
Preliminary study:
No data
Sex:
not specified
Dose descriptor:
other: minimum lethal dose
Effect level:
> 15.8 other: g/kg bw
Based on:
test mat.
Remarks on result:
other: No 95% confidence limits reported
Mortality:
No mortality
Clinical signs:
No significant toxic effects
Body weight:
No significant toxic effects
Gross pathology:
No significant toxic effects
Other findings:
None reported
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study DUP is virtually non-toxic
Executive summary:

The acute oral toxicity (LD50) of the substance in the rat is in excess of 15.8 g/kg body weight

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
15 800 mg/kg bw

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
Study period:
From October 19,2009 to November 3,2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant study conducted to recognised international test guidelines
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure
Limit test:
no
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:Harlan Italy S.r,l
- Age at study initiation:6/8 weeks old
- Weight at study initiation:176-200 g
- Housing: policarbonatecages measuring 42 .5 x 26.6 x 18 cm with stainless stell mesh lid and floor
- N° of animal/cage: Individually caged (both during acclimatisation and study)
- cage try control: Daily inspected and changed as necessary (at least 3 times/week)
- Diet: 4 RF 18 (Mucedola S.r,l)
- Diet supply: ad libitum
- Water :ad libitum
- Acclimation period:5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°c +/- 2°c
- Humidity (%):55% +/- 2°C
- Air changes: 15 to 25 air changes per hour
- Photoperiod: Artificial (fluorescent tubes) , daily light/dark cycle of 12/12 hours
Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure:approximately 10% of body surface
- Type of wrap if used:synthetic film

REMOVAL OF TEST SUBSTANCE
- Washing : After exposure , the adhesive bandage and gouze patch were removed. The treatment area was cleaned by gentle swabbing of the skin with cotton wool soaked with lukewarm water.
- Time after start of exposure:24 hours

TEST MATERIAL
- Amount(s) applied : Aliquots were weighed accordingly to the body weight of each animal measured prior dosing
- Constant volume or concentration used: yes
- Frequency of treatment: once only , on the day of dosing
- Treatment area preparation: on the day before dosing

Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 male and 5 female rats
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days , termination on day 15.
- Frequency of observations and weighing:days 1,8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: necropsy was carried out on all animals (gross necropsy examination for both internal and external abnormalities, with particular attention to the treatment site. All abnormalities were recorded.
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:
None during 14 day post-exposure observation period
Clinical signs:
No abnormalities were found at necropsy examination performed on all animals at termination of the study.
Body weight:
Changes in body weight were within the expected range for this species and age of animals at the end of the study.
Gross pathology:
no pathology observed
Other findings:
None

 

 

 

 

 

 

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute toxicity of 1,2-benzenedicarboxylic acid, diundecyl alkyl ester was investigated following dermal administration of a single dose to the rat at 2000 mg/kg. No mortality occurred following dosing and no signs of toxicity were observed.
These results indicate that the test item, 1,2-benzenedicarboxylic acid, diundecyl alkyl ester, has no toxic effect on the rat following dermal exposure over a 24 hour period at a level of 2000 mg/kg. The lack of mortality demonstrates the LD50 to be greater than 2000 mg/kg.European Directives concerning the classification, packaging and labelling of dangerous substances and mixtures (Regulation (EC) no. 1907/2006, 1272/2008 and subsequent revisions) would indicate the following:

Classification : Not required
Signal word : None indicated
Hazard statement : None indicated
Executive summary:

Acute dermal has been investigated following administration of a single dose to the rat at a level of 2000 mg/kg. No mortaility occurred, demonstrating the LD50 to be greater than 2000 mg/kg.

 

         

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Acute oral toxicity has been investigated following administration of a single oral dose. The LD50 was demonstrated to be in excess of 15800 mg/kg.

Acute dermal toxicity has been investigated following administration of a single dose to the rat at a level of 2000 mg/kg. No mortaility occurred,demonstrating the LD50 to be greater than 2000 mg/kg. In the rabbit, a LD50 in excess of 7940 mg/kg body weight has been reported.

Six hours exposure to a saturated vapour concentration of 1.8 mg/L, resulted in no mortality. The vapour concentration tested is considered to represent the highest achievable.

Justification for classification or non-classification

Non-classification justified by lack of observed toxicity following single exposures by the oral, dermal and inhalation routes.