Registration Dossier

Administrative data

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.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1972
Report Date:
1972

Materials and methods

Test guideline
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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): Ethfac -- Sample # 251 B
- Composition of test material: Ethoxylated lauryl phosphate
- Lot/batch No.: Monsanto Sample Number 66

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals 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)

Administration / exposure

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

Results and discussion

Effect levelsopen allclose all
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:
Clinical signs included reduced appetite and activity (2 to 4 days in surviving animals), increasing weakness and collapse.
Body weight:
Body weights of Female #1 and Male #2 were unchanged or decreased by 0.1 kg, respectively, 5 days after dosing.
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.

Applicant's summary and conclusion

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.