Diundecyl phthalate, branched and linear

Endpoint summary

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 or test system 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:

other: 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

Guideline:

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

Deviations:

no

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

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: 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:

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

 

 

 

 

 

 

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.