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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Administrative data

Description of key information

Acute oral screening tests on two structural analogs: LD50 in female rats > 2000 mg test material/kg bw, no mortalities occured in any animals in both studies, no adverse effects were observed.
Acute dermal toxicity study on one structural analog: Minimal Lethal Dose in rabbits higher than 3160 mg/kg bw and lower or equal to 5010 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
Two screening tests were available with good reliability (Kr. 2). The tests were performed in compliance with international guidance requirements with acceptable restrictions.

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:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1972
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
This study on CAS 39464-66-9 is deemed appropriate for read-across on this endpoint, based on the following considerations: - CAS 39464-66-9, described as polyoxyethylene lauryl ether phosphate, is a direct structural analogue of the unsalified form of Dermalcare MAP L213S. - The molecular weight (> 300) and logKow (< -1) of Dermalcare MAP L213S are in favor of low dermal penetration [Kroes et al. Food Chem Toxicol. 45: 2533-62, 2007] and therefore no significant systemic toxicity is expected following dermal exposure. - The conclusion of the study allows appropriate Classification & Labelling of the test substance.
Qualifier:
no guideline followed
Principles of method if other than guideline:
US TSCA Section 8(e) Compliance Audit Program
GLP compliance:
no
Remarks:
Not applicable (study period before GLP implementation)
Test type:
other: The undiluted compound was applied in increasing doses at increments of 0.2 fractional log intervals to the closely clipped, intact skin of New-Zealand White male and female rabbits.
Limit test:
no
Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
- Animals held in wooden stocks for periods up to 24 hours after dosing, after which time they were assigned to individual cages.
- Weight at study initiation: 2.2 and 2.3 kg (females) and 2.4 and 2.6 kg (males)
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
The undiluted test material was applied to the closely clipped, intact skin of the rabbits. The treated areas were covered with plastic strips.
Duration of exposure:
Single exposure.
Doses:
2000 and 5010 mg/kg bw (females) and 3160 and 7940 mg/kg bw (males)
No. of animals per sex per dose:
2 males + 2 females
Control animals:
no
Details on study design:
Observations were made for signs of toxicity and the viscera of the test animals were examined macroscopically. Surviving animals were sacrified 14 days after dosing.
Statistics:
No
Sex:
male
Dose descriptor:
other: Minimal Lethal Dose
Effect level:
> 3 160 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
other: Minimal Lethal Dose
Effect level:
<= 5 010 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred in Female #1 and Male #2 given 2000 and 3160 mg/kg bw, respectively.
Female #3 given 5010 mg/kg bw died 3 days after dosing.
Male #4 given 7940 mg/kg bw died 2 days after dosing.
Clinical signs:
other: Clinical signs included reduced appetite and activity (2 to 4 days in surviving animals), increasing weakness and collapse.
Gross pathology:
At necropsy, lung and liver hyperemia, slightly enlarged gall bladder and gastrointestinal inflammation was noted in animals found dead. The viscera appeared normal in surviving animals sacrificed 14 days after dosing.
Interpretation of results:
sligthly toxic
Remarks:
Migrated information Criteria used for interpretation of results: other: US EPA TSCA
Conclusions:
The minimal lethal dose in 2 out of 4 tested rabbits was higher than 3160 mg/kg bw but lower or equal to 5010 mg/kg bw. The substance should therefore be considered as Acute Tox. 5, H313 (May be harmful in contact with skin) according to the UN-GHS classification criteria, but is not classified for acute dermal toxicity according to DSD or CLP criteria.
Executive summary:

Undiluted ethoxylated lauryl phosphate (CAS 39464 -66 -9) was applied to the closely clipped, intact skin of New-Zealand White rabbits, at the doses of 2000 (one female), 3160 (one male), 5010 (one female) and 7940 (one male) mg/kg bw.

The treated skin areas were covered with plastic strips. Observations were made for mortality or signs of toxicity and the viscera of the test animals were examined macroscopically. Surviving animals were sacrificed 14 days after dosing.

No mortality occurred in Female #1 and Male #2 given 2000 and 3160 mg/kg bw, respectively. Female #3 given 5010 mg/kg bw died 3 days after dosing. Male #4 given 7940 mg/kg bw died 2 days after dosing. Clinical signs included reduced appetite and activity (2 to 4 days in surviving animals), increasing weakness and collapse. Body weights of Female #1 and Male #2 were unchanged or decreased by 0.1 kg, respectively, 5 days after dosing. At necropsy, lung and liver hyperemia, slightly enlarged gall bladder and gastrointestinal inflammation was noted in animals found dead. The viscera appeared normal in surviving animals sacrificed 14 days after dosing.

The minimal lethal dose in 2 out of 4 tested rabbits was higher than 3160 mg/kg bw but lower or equal to 5010 mg/kg bw. The substance should therefore be considered as Acute Tox. 5, H313 (May be harmful in contact with skin) according to the UN-GHS classification criteria, but is not classified for acute dermal toxicity according to DSD or CLP criteria.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
discriminating dose
Quality of whole database:
Study dated 1972, compliant with standards in force in USA at the time, but of good reliability (Kr. 2) and allowing proper Classification & Labelling of the substance.

Additional information

Data available on two analogs of Dermalcare MAP L213/S satisfy the acute oral toxicity endpoint requirements for an Annex VII or VIII dossier based on a weight of evidence approach. The studies are screening tests but are scientifically acceptable and of good quality.

Data available on one analog of Dermalcare MAP L213/S satisfy the acute dermal toxicity endpoint requirements for an Annex VIII dossier based on a read-across approach. This study allows proper Classification & Labelling of the substance.


Justification for selection of acute toxicity – oral endpoint
No study selected because a weight of evidence approach was used based on several data available for structural analogs of Dermalcare MAP L213/S (for justification of read-across between Dermalcare MAP L213S and its analogues, please refer to corresponding assessment report in Section 13).

Justification for selection of acute toxicity – dermal endpoint
Only one study available.

Justification for classification or non-classification

Harmonized classification:

No harmonized classification is available according to the Regulation (EC) No 1272/2008 including ATP2.

Self classification:

Dermalcare MAP L213/S is not classified for acute oral toxicity according to Regulation (EC) 1272/2008 (CLP) and to Directive 67/548/EEC as the oral LD50 (rats) is higher than 2000 mg test material/kg bw.

Dermalcare MAP L213/S is not classified for acute dermal toxicity according to Regulation (EC) 1272/2008 (CLP) and to Directive 67/548/EEC as the Minimal Lethal Dose (rabbits) is higher than 2000 mg test material/kg bw.

No classification for acute inhalation toxicity is proposed due to a lack of data.