Barium 4-dodecylphenolate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2019-10-05 to 2020-01-14

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2020

Report date:

2020

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

2017-10-09

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

signed 2019-09-16

Test type:

fixed dose procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Barium 4-dodecylphenolate

EC Number:

300-141-0

EC Name:

Barium 4-dodecylphenolate

Cas Number:

93922-04-4

Molecular formula:

C18H30O.1/2Ba

IUPAC Name:

barium 4-dodecylphenolate

Test material form:

solid

Details on test material:

- State of aggregation: brownish, inhomogeneous solid with a chewy texture

Specific details on test material used for the study:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: ambient (21 to 29° C); dry and protected from light in the original container

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: due to the physical-chemical properties of the test item, the test item was stirred and heated to 50 - 55° C for 21 minutes prior to administration in order to facilitate homogenous sampling of the test material. The test material was allowed to cool overnight before application to the animals.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: in-house bred animals
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 9 to 11 weeks
- Weight at study initiation: 2000 mg/kg bw dose level group: 201.68 g to 203.40 g; 2959 mg/kg bw dose level group: 229.24 g to 235.40 g
- Housing: housed in a standard polypropylene cage (size: L 430 x B 285 x H 150 mm) with stainless steel mesh top grill; range finding study: housed individually after treatment throughout the observation; main study: during treatment, the animals were housed individually and after patch removal they were housed together; bedding material: clean sterilized paddy husk; environmental enrichment: paper shredding
- Diet (ad libitum): Altromin maintenance diet for rats and mice (manufactured by Altromin Spezialfutter GmbH & Co. KG)
- Water (ad libitum): deep bore-well water passed through Reverse osmosis unit
- Acclimation period: 5 days (range finding study); 11 and 10 days (main study; 2000 and 2959 mg/kg body weight, respectively)

ENVIRONMENTAL CONDITIONS
- Temperature: 19.3 ° C to 22.9° C
- Relative humidity: 42% to 67%
- Air changes: 12 to 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST MATERIAL
The first dose level tested was 2000 mg/kg bw of the test item. However, a correction for water content of the test item (32.4%) was not taken into account and the dose level used was not equivalent to a limit dose level of 2000 mg/kg bw (actual received dose: 1352 mg/kg bw after correction for water content). Therefore, further testing at another dose level of 2959 mg/kg (actual dose: 2000 mg/kg bw after correction for water content) was considered necessary.

TEST SITE
- Area of exposure /% coverage/ Type of wrap if used: on the day, before the application of the test item, fur from the dorso-lateral area of the trunk of the animals was removed by clipping closely with an electric hair clipper (approximately 10% of surface area of body). Care was taken to avoid abrading the skin.
Required quantity of the test item per animal (based on the individual animal day 1 body weight) was weighed on to aluminium foil. Prior to the test item application, the treatment area was covered with a nylon mesh in order to facilitate the removal of the test substance. Then, the test item was taken on to porous gauze dressing which was then applied uniformly over an area which is at least 10% of the total body surface area. The porous gauze dressing is then wrapped with non-irritating adhesive tape and finally, the application site was wrapped using crepe bandage.

REMOVAL OF TEST SUBSTANCE
- Washing: the residual test item was removed with corn oil from the skin and the skin was dried with absorbent cotton.
- Time after start of exposure: at the end of the contact period

Duration of exposure:

24 hours

Doses:

2000 and 2959 mg/kg bw

No. of animals per sex per dose:

3 females (Range finding study: 1 female; main study: 2 females)

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days

- Frequency of observations and weighing: all the animals were observed for clinical signs of toxicity and mortality at 20 to 30 min, 1 hr (±10 mins), 2 hrs (±10 mins), 4 hrs (±10 mins) and 6 hrs (±10 mins) post dosing on Day 1 and thereafter once daily for clinical signs of toxicity and twice daily for mortality during the 14 days observation period. Furthermore, the treatment site was observed at 24, 48 and 72 hours after removal of test item using the Draize method.
Individual animal body weight was recorded at receipt, on day 1 before test item application, on day 8 and 15 during the experimental period.

- Necropsy of survivors performed: yes, on day 15, all the animals were humanely sacrificed by carbon dioxide asphyxiation and subjected to necropsy and a complete gross pathological examination.

Statistics:

not applicable

Results and discussion

Preliminary study:

not applicable

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 959 mg/kg bw

Based on:

test mat.

Remarks on result:

other: (equivalent to the limit dose of 2000 mg/kg bw after correction for water content (32.4 %))

Mortality:

- 2000 and 2959 mg/kg bw: no animal died in either the range finding study or the main study animals.

Clinical signs:

other: - 2000 mg/kg bw: erythema was observed from day 2 to day 4 and all the observations reversed back to normal on day 5. - 2959 mg/kg bw: erythema was observed from day 2 to day 6 and all the observations reversed back to normal on day 7.

Gross pathology:

- 2000 and 2959 mg/kg bw: no treatment related gross pathological changes were observed in any of the animals of the range finding study or the main study at any dose level.

Other findings:

Skin reactions:
- 2000 mg/kg bw: very slight erythema (barely perceptible) was observed for the range finding study animal as well as main study animals at the treatment sites at 24 and 48 hours after test item removal. All observations reversed back to normal at 72 hours after removal of test item. No oedema was observed for any animal at 24, 48, and 72 hour observations following test item removal.

- 2959 mg/kg bw: very slight erythema (barely perceptible) was observed in both range finding study and main study animals at the treatment sites at 24, 48 and 72 hour observations after removal of test item. No oedema was observed for any animal at 24, 48, and 72 hour observations following test item removal.

The mean score across scoring times (24, 48 and 72 hours after patch removal) for both range finding study and main test animals was '0.67' for erythema and '0' for oedema for the dose level 2000 mg/kg bw and '1' for erythema and '0' for oedema for the dose level 2959 mg/kg bw.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

LD50 (female rats) > 2959 mg/kg bw (equivalent to the limit dose of 2000 mg/kg bw after correction for water content (32.4 %))
The substance does not require classification for acute dermal toxicity according to Regulation (EC) No 1272/2008 and its subsequent amendments.