Poly[oxy(methyl-1,2-ethanediyl)], .alpha.-[2-[[2,2-dimethyl-3-[(1-oxododecyl)oxy]propylidene]amino]methylethyl]-.omega.-[2-[[2,2-dimethyl-3-[(1-oxododecyl)oxy]propylidene]amino]methylethoxy]-

Endpoint summary

Description of key information

Oral: The acute oral LD50 obtained for the test item was found to be greater 2000 mg/kg bw.

Dermal: To assess the acute dermal toxicity of Sika Hardener LJ, read across was applied using toxicological data from the hydrolysis product 2,2-Dimethyl-3-lauroyloxy-propanal. Based on the findings of an acute dermal toxicity study, a single 24-hour dermal administration of the hydrolysis product did not induce any test item related adverse effects and a LD50 > 2000 mg/kg bw was derived.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2012-02-28 to 2012-03-15

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

December 2001

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Version / remarks:

May 2008

Deviations:

no

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Version / remarks:

December 2002

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

Wistar

Remarks:

Crl(WI)Br

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
-Source: Toxi-Coop Zrt. 1103 Budapest, Cserkesz u. 90
- Age at study initiation: Young adult rats, 9 weeks old
-Weight at study initiation: 195-216 g
- Fasting period before study: food but not water was withheld overnight
- Housing: 3 animals/sex/cage
- Diet: ad libitum (ssniff® SM R/M-Z+H complete diet )
- Water: ad libitum
- Acclimation period: 12 days in first step and 13 days in second step

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 8-12 air exchanges/hour by central air-condition system.
- Photoperiod: Artificial light, from 6 a.m. to 6 p.m.

Route of administration:

oral: gavage

Vehicle:

other: Helianthi Annui Oleum Raffinatum

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/L
- Amount of vehicle: 10 mL/kg bw
- Justification for choice of vehicle: good solubity
- Lot/batch no.: 2011.03.04.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 females/group
In total 2 groups with 3 females each were tested.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Weighing 4 times every 7 day; Clinical observation- once during the first 30 min. , then 1h, 2h, 3h, 4h after treatment and on 14th day
- Necropsy of survivors performed: yes
- Other examinations performed: gross pathology

Statistics:

not applicable

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

>= 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No death occurred at 2000 mg/kg single oral dose of the test item. All rats survived until the end of the 14-day observation period.

Clinical signs:

other: No treatment related symptoms were observed throughout the treatment and 14-day post-treatment period at any groups of the female animals.

Gross pathology:

All animals treated with 2000 mg/kg bw dose of the test item survived until the scheduled necrospy on day 15.
No pathological changes were found related to the effect of the test item during the macroscopic examination of the animals. Beside in animal no.: 2873 of the group 1 there were observed slight hydrometra connected to the cycle of the animal.

Other findings:

None.

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral LD50 obtained for the test item was found to be greater 2000 mg/kg bw.

Executive summary:

In this acute oral toxicity study, two groups of female rats (Crl(WI)Br) were given a single oral dose of the test item SIKA Hardener LJ at a concentration of 2000 mg/kg bw. The starting dose was selected on the basis of the available information about the test item.

The acute toxic class method was carried out involving a stepwise procedure with the use of 2000 mg/kg bw as the starting dose in three female rats. No animal died in the first step at 2000 mg/kg bw dose level. Therefore, treatment with 2000 mg/kg bw was repeated on further three female rats. Again, no animal died in the second step, thus no further testing was required. The stopping criteria of Annex 2d of OECD Guideline No. 423 were met.

Animals were weighed, observed for lethality and toxic symptoms for 14 days after the treatment. Gross pathological examination was carried out on the 15th day after the treatment.

There were no effects on mean body weight and body weight gain. No clinical symptoms were observed and all organs of the animals treated with 2000 mg/kg bw dose proved to be free of treatment related gross pathological changes.

According of the results from this study the LD50 obtained for the test item was found to be o be greater 2000 mg/kg bw. Therefore, there is no classification required for the test item SIKA Hardener LJ.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

GLP and guideline study.

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:

2004-09-10 - 2004-10-13

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

February 24th 1987

Deviations:

no

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

Decembre 29th 1992

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: CHARLES RIVER (EUROPE) LABORATORIES INC.
- Age at study initiation: less than ten weeks old
- Weight at study initiation: male: 248 - 255g; female: 172 - 190g
- Housing: individual caging (1 animal/cage)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 13 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): 8 - 12
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: trunk of the animals
- % coverage: approximately 10%
- Type of wrap if used: plastic wrap

REMOVAL OF TEST SUBSTANCE
- Washing: with body temperature water
- Time after start of exposure: 24 h

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

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 animals/sex

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations were done once each day, weighing was done on day 0, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

other: In male and female animals of 2000 mg/kg bw dose level all treated animals were symptom-free during the study. During the observation period the behaviour and general state of animals were normal.

Gross pathology:

In the male dose group of 2000 mg/kg bw, emphysema (4/5 male, 3/5 female) and pinprick-sized haemorrhages (1/5 male 2/5 female) were observed in the lungs. No macroscopic alterations due to the toxic effect of the test item were found. The pulmonary emphysema and the pinprick-sized haemorrhages observed during the necropsy might be related to the method of anaesthesia and are also observed in untreated animals.

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the findings on the present study, a single 24-hour dermal administration did not induce any test item related adverse effects and a LD50 > 2000 mg/kg bw was derived.

Executive summary:

The acute dermal toxicity study (Limit Test) according to OECD 402 was performed with 2,2-Dimethyl-3-lauroyloxy-propanal. Five male and 5 female CRL (WI) BR Wistar rats were treated (single 24-hour semi-occlusive dermal application) with undiluted 2,2-Dimethyl-3-lauroyloxy-propanal at a dose level of 2000 mg/kg bw. None of these animals died. Clinical signs or dermal symptoms were not observed during the 14 days post-treatment observation period. No effects on mean body weight and body weight gain were noted for these dose groups. Specific macroscopic alterations related to the toxic effect of the test item 2,2-Dimethyl-3-lauroyloxy-propanal were not found. The acute dermal LD50 value is above 2000 mg/kg bw in male and female CRL: (WI) BR rats.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

GLP and guideline study.

Additional information

Acute oral toxicity study:

In this acute oral toxicity study, two groups of female rats (Crl(WI)Br) were given a single oral dose of the test itemSIKA Hardener LJ at a concentration of 2000 mg/kg bw. The starting dose was selected on the basis of the available information about the test item.

The acute toxic class method was carried out involving a stepwise procedure with the use of 2000 mg/kg bw as the starting dose in three female rats. No animal died in the first step at 2000 mg/kg bw dose level. Therefore, treatment with 2000 mg/kg bw was repeated on further three female rats. Again, no animal died in the second step, thus no further testing was required. The stopping criteria of Annex 2d of OECD Guideline No. 423 were met.

Animals were weighed, observed for lethality and toxic symptoms for 14 days after the treatment. Gross pathological examination was carried out on the 15th day after the treatment.

There were no effects on mean body weight and body weight gain. No clinical symptoms were observed and all organs of the animals treated with 2000 mg/kg bw dose proved to be free of treatment related gross pathological changes.

According of the results from this study the LD50 obtained for the test item was found to be o be greater 2000 mg/kg bw. Therefore, there is no classification required for the test item SIKA Hardener LJ.

Acute dermal toxicity study:

The acute dermal toxicity study (Limit Test) according to OECD 402 was performed with 2,2-Dimethyl-3-lauroyloxy-propanal. Five male and 5 female CRL (WI) BR Wistar rats were treated (single 24-hour semi-occlusive dermal application) with undiluted 2,2-Dimethyl-3-lauroyloxy-propanal at a dose level of 2000 mg/kg bw. None of these animals died. Clinical signs or dermal symptoms were not observed during the 14 days post-treatment observation period. No effects on mean body weight and body weight gain were noted for these dose groups. Specific macroscopic alterations related to the toxic effect of the test item 2,2-Dimethyl-3-lauroyloxy-propanal were not found.The acute dermal LD50 value is above 2000 mg/kg bw in male and female CRL: (WI) BR rats.

Justification for classification or non-classification

Based on data available for acute toxicity, the substance was not classified and labelled for acute oral and dermal toxicity according to Regulation (EC) No 1272/2008, as amended for the fifteenth time in Regulation (EU) No 2020/1182.