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Administrative data

Description of key information

Acute Toxicity - Oral: Based on the results of this study, the acute lethal oral dose (LD50) of Molyvan 855 was estimated to be greater than 5 g/kg of body weight in male and female rats.  
Acute Toxicity - Dermal: Based on the results of this study, the acute lethal dermal dose (LD50) of Molyvan 855 was estimated to be greater than 2.0 g/kg of body weight in New Zealand White Rabbits.

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted similar to OECD Guideline under GLP conditions.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Rats were obtained from Charles River Breeding Laboratories, Inc. Housing and Care conformed to the standards established in the "Guide for the Care and Use of Laboratory Animals" DHEW Publication No. (NIH) 85-23. Acclimation period of at least 5 days. Animals were fasted overnight prior to proceeding a single oral dose.
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Single oral dose by gavage
Doses:
5.0 g/kg bw
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
Similar to OECD TG 401. Single oral dose 5 male/5 female rats with 15-day post-administration observation period.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 other: g/kg
Based on:
test mat.
Mortality:
All animals survived the 15-day post observation period. No deaths occurred.
Clinical signs:
Effect Males Females
Salivation 3/5 4/5
Diarrhea 1/5 2/5
Decreased activity 1/5 1/5
Decreased Resp rate 0/5 2/5
Body weight:
Mean BW data
Initial Day 8 Day 15
Males: 306.4 364.4 394.6
+ or - 9.2 (5) + or - 10.1 (5) + or- 11.8 (5)

Females 220.6 247.6 255.2
+ or - 9.7 (5) +or- 13.1 (5) +or-14.7 (5)

Standard Deviation for the number of observations in ( ). The initial weight is based on fasted body weight.
Gross pathology:
All animals were subject to gross necropsy. There were no noteworthy findings.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of this study, the acute lethal oral dose (LD50) of Molyvan 855 was estimated to be greater than 5 g/kg of body weight in male and female rats.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
5 000 mg/kg bw
Quality of whole database:
1

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted similar to OECD Guideline under GLP conditions.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
10 young adult NZ white rabbits were obtained from Ace Animals, Inc for use in this study. All housing and care conformed to the standards established in the "Guide for the Care and Use of Laboratory Animals" DHEW Publication No. (NIH) 85-23. All animals were acclimated for a minimum of at lead 5 days. During this acclimation period, the rabbits were examined with respect to their general health to assure their suitability as test animals.
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24 hours
Doses:
2.0 g/kg bw
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
On the day prior to dosing, the back of each rabbit was clipped free of fur with electric clippers. The test article was administered to intact skin under an occlusive binder at a level of 2.0 g/kg bw. The binder consisted of a layer of plastic wrap and stockinette sleeve all securely held in place with masking tape. Animals were evaluated at the end of the 15-day post application observation period.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 other: g/kg bw
Based on:
test mat.
Mortality:
No deaths occurred
Clinical signs:
Observation Males Females
Soft stools 3/5 0/5
Nasal discharge 1/5 0/5
Anorexia 1/5 0/5
Body weight:
Mean Body weight data (kg)
Initial Day 8 Day 15
Males 2.20 2.27 2.43
+ or-0.23 (5) +or-0.16(5) +or-0.22(5)

Females 2.32 2.40 2.48
+or-0.14(5) +or-0.20(5) +or -0.36(5)

Values are means +or- standard deviations for the number of observations in ( ).
Gross pathology:
No noteworthy findings.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of this study, the acute lethal dermal dose (LD50) of Molyvan 855 was estimated to be greater than 2.0 g/kg of body weight in New Zealand White Rabbits.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw
Quality of whole database:
1

Additional information

Acute Toxicity - Oral route

Key study

In an OECD 401 study conducted according to GLP, using male and female SD rats, the oral LD50 of Molyvan 855 is greater than 5 g/kg of body weight (Food and Drug Research Laboratories, Inc, 1985).

Acute Toxicity - Inhalation route

Data Waiver

According to 8.5.2 Column 2 Annex VIII of Regulation (EC) 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), the acute toxicity, via inhalation route, of a substance does not need to be conducted if exposure of humans via inhalation is unlikely, taking into account the vapour pressure (for liquids) and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size. Molyvan 855 has a vapour pressure of lss than 0.00042 kPa, thus human exposure is considered unlikely, therefore, this endpoint is waived.

Acute Toxicity - Dermal route

Key study

In an OECD 402 study conducted according to GLP, using male and female New Zealand White Rabbits, the dermal LD50 of Molyvan 855 is greater than 2.0 g/kg of body weight.


Justification for selection of acute toxicity – oral endpoint
Well conducted study similar to OECD Guideline 401 and GLP.

Justification for selection of acute toxicity – inhalation endpoint
According to 8.5.2 Column 2 Annex VIII of Regulation (EC) 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), the acute toxicity, via inhalation route, of a substance does not need to be conducted if exposure of humans via inhalation is unlikely, taking into account the vapour pressure (for liquids) and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size. Molyvan 855 has a vapour pressure of lss than 0.00042 kPa, thus human exposure is considered unlikely, therefore, this endpoint is waived.

Justification for selection of acute toxicity – dermal endpoint
Well conducted study similar to OECD Guideline 402 and GLP.

Justification for classification or non-classification

Oral route:

The oral LD50 of Molyvan 855 is >5,000 mg/kg b.w., therefore, according to Regulation EC No. 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures, Table 3.1.1, Molyvan 855 is not classified for Acute Oral Toxicity.

Dermal route:

The dermal LD50 of Molyvan 855 is estimated to be >2 g/kg b.w., therefore, according to Regulation EC No. 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures, Table 3.1.1, Molyvan 855 is not classified for Acute Dermal Toxicity.