[No public or meaningful name is available]

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Diundecyl phthalate

EC Number:

222-884-9

EC Name:

Diundecyl phthalate

Cas Number:

3648-20-2

IUPAC Name:

diundecyl phthalate

Details on test material:

- Name of test material (as cited in study report):1,2-benezenedicarboxylic acid, diundecyl alkyl ester
- Physical state:light yellowish clear undefined liquid
- Analytical purity:99.62%
- Expiration date of the lot/batch:08 july 2010
- Storage condition of test material:ambient temperature
- Lot/batch No.:Partita n° 5-6 foglio di marcia n° 2 del 24/05/09

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system 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: polycarbonate cages 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

Administration / exposure

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 gauze 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.

Results and discussion

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

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:

other: No abnormalities were found at necropsy examination performed on all animals at termination of the study.

Gross pathology:

no pathology observed

Other findings:

None

Any other information on results incl. tables

 

 

 

 

 

 

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

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 mortality occurred, demonstrating the LD50 to be greater than 2000 mg/kg.