1,2-Benzenedicarboxylic acid, di-C16-18-alkyl esters

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

01 Feb - 18 Jun 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP - Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,2-Benzenedicarboxylic acid, di-C16-18-alkyl esters

EC Number:

290-580-3

EC Name:

1,2-Benzenedicarboxylic acid, di-C16-18-alkyl esters

Cas Number:

90193-76-3

Molecular formula:

C40H70O4, C42H74O4, C44H78O4

IUPAC Name:

1,2-Benzenedicarboxylic acid, di-C16-18(even numbered)-alkyl esters

Details on test material:

- CAS No. of test material (as cited in study report): 90193-76-3
- Physical state: White powder (determined at NOTOX)
- Analytical purity: 97%
- Lot/batch No.: C000627-001
- Expiration date of the lot/batch: 29 January 2011 (allocated by NOTOX, 1 year after receipt of the test substance)
- Stability under storage conditions: Stable
- Stability at higher temperatures: No, the product becomes sticky and starts to melt
- Stability in vehicle: Ethanol: At least 2 hours
- 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
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: 10 weeks old
- Weight at study initiation: Body weight variation did not exceed ± 20% of the sex mean
- Housing: Makrolon cages (MIII type, height 18 cm.) containing sterilized sawdust as bedding material (Litalabo, S.P.P.S., Argenteuil, France) and paper as cage-enrichment (Enviro-dri, Wm. Lillico & Son (Wonham Mill Ltd), Surrey, United Kingdom)
- Diet: Free access to pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany)
- Water: tap water ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): .0 ± 3.0ºC (actual range: 20.0 – 21.7ºC)
- Humidity (%): 40-70% (actual range: 41 - 53%)
- Air changes (per hr): air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light and 12 hours darkness per day

Administration / exposure

Type of coverage:

occlusive

Vehicle:

corn oil

Details on dermal exposure:

TEST SITE
- Area of exposure: an area of approximately 5x7 cm on the back of the animal was clipped
- % coverage: 10% of the total body surface, i.e. approx. 25 cm² for males and 18 cm² for females
- Type of wrap if used: gauze patch (Surgy 1D), successively 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): the skin was cleaned of residual test substance using tap water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 mL/kg body weight

Duration of exposure:

24 hours

Doses:

2000 mg/kg

No. of animals per sex per dose:

5 males and 5 females (females were nulliparous and non-pregnant)

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: mortality: 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
- Other examinations performed: clinical signs, body weight

Statistics:

Not required

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study period.

Clinical signs:

other: Chromodacryorrhoea on the snout was noted in the majority of animals and piloerection and/or hunched posture were also noted for several animals. The animals had fully recovered from the symptoms between Days 2 and 3. No signs of dermal irritation were ob

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:

CLP: not classified
DSD: not classified