Reaction mass of 2,2',2''-nitrilotriethanol and disodium succinate and sodium acetate and sodium bromide

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2013-01-30 to 2013-04-17

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: study according to OECD TG 402 (1987), EU Method B3 (2008) and OPPTS 870.1200 (1998) and under GLP

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (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:

Reaction Mass of CXN1-55

IUPAC Name:

Reaction Mass of CXN1-55

Details on test material:

- Name of test material (as cited in study report): Reaction mass of CXN1-55- Substance type: multi-constituent substance- Physical state: Paste- Stability under test conditions: substance considered stable under normal ambient conditions- Storage condition of test material: at room temperature at 20 ± 5 °C, 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: Harlan Laboratories UK Ltd., Oxon, UK- Age at study initiation: 8-12 weeks- Weight at study initiation: At the start of the study the animals weighed at least 200 g, and were eight to twelve weeks of age. The weight variation did not exceed ± 20 % of the mean weight for each sex.- Fasting period before study: no- Housing: The animals were housed individually during the 24-Hour exposure period and in groups of five, by sex, for the remainder of the study.- Diet: Free access to food (2014C Teklad Global Rodent diet supplied by Harlan Laboratories UK Ltd., Oxon, UK)- Water: free access- Acclimation period: at least five daysENVIRONMENTAL CONDITIONS- Temperature (°C): 19-25 °C- Humidity (%): 30-70 %- Air changes (per hr): the rate of air exchange was at least fifteen changes per hour- Photoperiod (hrs dark / hrs light): 12 hours / 12 hoursIN-LIFE DATES: From: 2013-01-30 To: 2013-02-13

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

water

Details on dermal exposure:

TEST SITE- Area of exposure: area of shorn skin- % coverage: approximately 10 % of the total body surface area- Type of wrap if used: A piece of surgical gauze was placed over the treatment area and semi occluded with a piece of self adhesive bandage.REMOVAL OF TEST SUBSTANCE- Washing: After the 24-Hour contact period the bandage was carefully removed and the treated skin and surrounding hair wiped with cotton wool moistened with distilled water to remove any residual test item.- Time after start of exposure: 24 hoursTEST MATERIAL- Amount(s) applied (volume or weight with unit): 2000 mg/kg body weight. The test item was weighed out according to each animal’s individual body weight and moistened with distilled water prior to application.- Concentration (if solution): no solution- Constant volume or concentration used: yes- For solids, paste formed: no, test item was weighed out according to each animal’s individual body weight and moistened with distilled water prior to application.

Duration of exposure:

24 hours

Doses:

2000 mg/kgy body weight

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days- Frequency of observations and weighing: 4 observations at the day of application, afterwards daily observations, weighing at day 0, 7 and 14- Necropsy of survivors performed: yes- Other examinations performed: clinical signs, body weight,histopathology

Statistics:

Data evaluations included the relationship, if any, between the exposure of the animal to the test item and the incidence and severity of all abnormalities including behavioral and clinical observations, gross lesions, body weight changes, mortality and any other toxicological effects. Using the mortality data obtained, an estimate of the acute dermal median lethal dose (LD50) of the test item was made.

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:

No deaths

Clinical signs:

other: No signs of systemic toxicity were noted during the observation period. No irritating effects observed at dose level 2000 mg/kg body weight.

Gross pathology:

No abnormalities were noted at necropsy.

Other findings:

Small superficial scattered scabs were noted at the test sites of two females at day 6 and 7 and were not detected afterwards. No other signs of dermal irritation were noted.

Applicant's summary and conclusion

Interpretation of results:

other: not acute dermal toxic up to and including 2000 mg/kg body weight

Conclusions:

In a conclusive, reliable and valid study, the acute dermal median lethal dose (LD50) of the test itemReaction mass of CXN1-55 in the Wistar strain rat was found to be greater than 2000 mg/kg body weight.

Executive summary:

In a reliable, conclusive and valid study, the acute dermal toxicity of the test item Reaction mass of CXN1-55 on the Wistar strain rat was determined according to OECD TG 402, Method B3 (EC) and US EPA, OPPTS 870.1200 under GLP.

A group of ten animals (five males and five females) was given a single, 24 hour, semi-occluded dermal application of the test item to intact skin at a dose level of 2000 mg/kg body weight. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.

Mortality: There were no deaths.

Clinical Observations: There were no signs of systemic toxicity.

Dermal Irritation: Transient small superficial scattered scabs were noted at the test sites of two females. No other signs of dermal irritation were noted.

Body Weight: Animals showed expected gains in body weight except for two females which showed expected gain in body weight during the first week and bodyweight loss during the second week.

Necropsy: No abnormalities were noted at necropsy.

Conclusion: The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000 mg/kg body weight.