Reaction mass of sodium sulphate and disodium dodecanedioate and Dodecanoic acid, 12-amino-, sodium salt (1:1)

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

07 July 2010 - September 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Compliant to GLP and testing guideline (the deviation was not considered to have compromised the validity of the study and results); adequate coherence between data, comments and conclusions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

all males had a body weight higher than 320 g (up to 355 g)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

yes

Remarks:

idem above

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of sodium sulfate, sodium amino-12-dodecanoate and sodium dodecanoediate

IUPAC Name:

Reaction mass of sodium sulfate, sodium amino-12-dodecanoate and sodium dodecanoediate

Details on test material:

- Name of test material (as cited in study report): Reaction mass of sodium sulfate, sodium amino-12-dodecanoate and sodium dodecanoediate
- Substance type: UVCB (substance of unknown or variable composition, complex reaction products or biological materials)
- Physical state: brown liquid
- Purity test date: 26 march 2009
- Lot/batch No.: T710/712
- Expiration date of the lot/batch: 20 September 2010
- Storage conditions of test material: at room temperature.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Breeder: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: approximately 8 weeks old
- Weight at study initiation: a mean body weight ± standard deviation of 353 ± 2 g for the males and 218 ± 9 g for the females
- Fasting period before study: none
- Housing: polycarbonate cages with stainless steel lid
- Diet (e.g. ad libitum): free access to SSNIFF R/M-H pelleted diet
- Water (e.g. ad libitum):f ree access to bottles containing tap water (filtered with a 0.22 µm filter)
- Acclimation period: at least 5 days before treatment.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2°C
- Humidity (%): 50 +/- 20%
- Air changes (per hr): approximately 12 cycles/hour of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12 h / 12 h

IN-LIFE DATES: From: 12 July 2010 To: 27 July 2010.

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: approximately 5 cm x 7 cm for males and 5 cm x 6 cm for females
- % coverage: approximately 10% of the total body surface area of the animals
- Type of wrap if used: a hydrophilic gauze pad held in place with an aerated hypoallergenic.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): on removal of the dressing, any residual test item was removed using a moistened cotton pad
- Time after start of exposure: 24 hours.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg (1.69 mL/kg)

Duration of exposure:

24 hours.

Doses:

2000 mg/kg.

No. of animals per sex per dose:

5 animals per sex and per dose.

Control animals:

other: historical control data

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: each animal was observed frequently during the hours following administration, for detection of possible treatment-related clinical signs then at least once a day for 14 day
- Necropsy of survivors performed: yes.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

None.

Clinical signs:

other: Exophthalmos, then corneal opacity, was observed on the left eye of one animal only from day 3 and day 12 to the end of the observation period, respectively. Erythema was noted on two males on days 2 and 3. Erythema was also noted on three, four and five

Gross pathology:

Macroscopic post-mortem examination of the main organs of the animals revealed no apparent abnormalities.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: other: Regulation EC no. 1272/2008

Conclusions:

The dermal LD50 of the test item Reaction mass of sodium sulfate, sodium amino-12-dodecanoate and sodium dodecanoedioate
(batch No. T710/712) was higher than 2000 mg/kg in rats.

Executive summary:

The objective of this study was to evaluate the toxicity of the test item, Reaction mass of sodium sulfate, sodium amino-12-dodecanoate and sodium dodecanoedioate (batch No. T710/712), following a single dermal application to rats according to OECD (No. 402, 24th February 1987) and Commission Regulation (EC) (No. 440/2008, Part B.3, 30 May 2008) guidelines .

The study was conducted in compliance with the principles of Good Laboratory Practice Regulations.

 

Methods

The test item, Reaction mass of sodium sulfate, sodium amino-12-dodecanoate, was applied undiluted for 24 hours to the skin of five male and five female Sprague‑Dawley rats at the dose‑level of 2000 mg/kg, then the test site was covered by a semi‑occlusive dressing.

Each animal was observed at least once a day for mortality and clinical signs for a period of up to 14 days following the single administration. Body weight was recorded on day 1 and then on days 8 and 15.

On completion of the observation period, the animals were sacrificed then subjected to a macroscopic post-mortem examination.

 

Results

No deaths were observed during the study. Exophthalmos, then corneal opacity, was observed on the left eye of one animal only from day 3 and day 12, respectively, to the end of the observation period.

Erythema was noted on two males on days 2 and 3. Erythema was also noted on three, four and five females on days 2, 3 and 4, respectively. It persisted on these females until day 10 (one female), day 14 (one female) and the end of the observation period (three other females).

A brown discoloration of the skin, was observed in 9/10 animals until day 3, and until day 8 in 1/10 animals. It masked the evaluation of local reactions in one of them until day 3. Scabs were observed from day 4 until the end of the observation period in one female only.

When compared to CIT historical control data, a lower body weight gain was noted between day 1 and day 8 in all males (from 25 to vs. 47 ± in control data base) and 1/5 females (11 g vs. 25 ± in control data base). The body weight gain of these animals returned to normal thereafter.

 

No apparent abnormalities were observed at necropsy in any animal.

Conclusion

Under the experimental conditions of this study, the dermal LD₅₀of the test item Reaction mass of sodium sulfate, sodium amino-12-dodecanoate and sodium dodecanoedioate (batch No. T710/712) was higher than 2000 mg/kg in rats.